Trachoma
Conditions
Keywords
CTH522, Chlamydia, C. Trachomatis
Brief summary
CHLM-02 was a phase I, double-blind, randomized, placebo-controlled trial of the chlamydia vaccine CTH522. 65 trial participants were randomized into 12 groups and six cohorts (A1 to F2). Cohorts A to E received three intramuscular (IM) injections of CTH522 (Day 0, 28, and 112). Cohorts A to D received CTH522 adjuvanted with Cationic Adjuvant Formulation (CAF®) 01 IM in two doses (85µg \[A to C\] or 15µg \[D\]). Cohort E received 85µg CTH522 adjuvanted with CAF®09b. Cohorts B and C received unadjuvanted CTH522 boost via the topic ocular (TO) or intradermal (ID) route, respectively, jointly with the second and third IM vaccinations. Cohort F received placebo. The effect of mucosal recall on eye immunity with TO CTH522 or placebo was assessed Day 140.
Detailed description
This trial was a phase I, double-blind, parallel, randomised, and placebo-controlled trial of the chlamydia vaccine CTH522 in healthy adults. It was planned to randomize 66 subjects but only 65 subjects were randomized. Cohorts A-D investigated CTH522-CAF01 administered IM in two doses (85 mcg and 15 mcg). Cohort E investigated CTH522-CAF09b administered IM in one dose (85 mcg). Cohort F was the placebo group. The enrolled subjects were to complete 12 trial visits. All subjects in the active cohorts (cohort A-E) were to receive three IM injections of the adjuvanted CTH522 and some (cohort B and C) were to receive the non-adjuvanted CTH522 via the TO or ID route (given at the same time as the 2nd and 3rd IM vaccinations). All active cohorts were to receive TO administration as a boost at Day 140 of either the non-adjuvanted CTH522 (12 mcg in each eye) or placebo. * Cohort A received three IM vaccination of 85 mcg CTH522-CAF01. This cohort was divided into two groups: A1 received ID placebo at Day 28 and Day 112, and TO placebo at Day 140, while A2 received TO placebo at Day 28 and Day 112, and non-adjuvanted TO CTH522 boost at Day 140. * Cohort B received three IM vaccinations of 85 mcg CTH522-CAF01. This cohort was divided into two groups: B1 received TO vaccination of the non-adjuvanted CTH522 at Day 28 and 112 and TO placebo at Day 140, while B2 received the same for Day 28 and 112, but non-adjuvanted TO CTH522 boost at Day 140. The two additional TO doses of CTH522 (12 mcg in each eye) were administered in each eye. The rationale for this schedule was to investigate the impact of simultaneous TO administration of the antigen on the immunogenicity results. * Cohort C received three IM vaccinations of 85 mcg CTH522-CAF01. This cohort was divided into two groups: C1 received ID vaccination of the non-adjuvanted 24 mcg CTH522 at Day 28 and 112 and TO placebo at Day 140, while C2 received the same for Day 28 and 112, but TO 12 mcg CTH522 boost in each eye at Day 140. The rationale for this schedule was to investigate the impact of simultaneous ID administration of the antigen on the immunogenicity results. * Cohort D received three IM vaccinations of 15 mcg CTH522-CAF01. The rationale for the A and D cohorts was to investigate the impact of the two IM CTH522 doses on the immunogenicity results. * Cohort E received three IM vaccinations of 85 mcg CTH522-CAF09b. The rationale for the A and E cohorts was to investigate the impact of the adjuvant on the immunogenicity results. * Cohort F received placebo in the form of 0.9% NaCl saline (IM, ID and TO).
Interventions
BIOLOGICALCTH522-CAF01 IM
On-site reconstitution of IMPs is performed by mixing 85 mcg CTH522 with CAF01. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 mL polypropylene Luer-Lok™ syringe via 23-25 gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.
BIOLOGICALCTH522-CAF09b IM
On-site reconstitution of IMPs is performed by mixing 85 mcg CTH522 with CAF09b. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 mL polypropylene Luer-Lok™ syringe via 23-25 gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.
BIOLOGICALCTH522 ID
24 mcg CTH522 given ID is in the non-dominant deltoid muscle. ID with a 1 mL syringe via a 26-28 gauge needle using a NanoPass device or similar. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.
BIOLOGICALCTH522 TO
24 mcg CTH522 (12 mcg in each eye) TO administrations will be performed using a Gilson positive displacement pipette. The identity of vaccine will be known to the clinical site staff dispensing/administrating the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.
BIOLOGICALPlacebo (Saline)
Placebo only given as IM, ID and TO.
Sponsors
Imperial College London
Statens Serum Institut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
IC1: Healthy males and females between 18-45 years old on the day of the first vaccination. IC2: Has been properly informed about the trial and signed the consent form. IC3: Is willing and likely to comply with trial procedures. IC4: Is prepared to grant authorised persons access to his/her trial-related medical record. IC5: Is willing to use acceptable contraceptive measures during the trial (two weeks before and two weeks after the trial). Heterosexually active female capable of becoming pregnant must agree to use hormonal contraception, intrauterine device, intrauterine hormone releasing system, or to complete abstinence from at least two weeks before the first vaccination until at least two weeks after the last. Complete abstinence (defined as refraining from heterosexual intercourse) must be in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods), withdrawal and progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, are not acceptable methods of contraception.
Exclusion criteria
EX1: Is positive for C. trachomatis via urine PCR or has a known history of C. trachomatis. EX2: Is positive for gonorrhoea via urine PCR test, or HIV, hepatitis B/C, syphilis via blood tests. EX3: Has a significant active disease such as cardiac, liver, immunological, neurological, psychiatric, or clinically significant abnormality of haematological or biochemical parameters. EX4: Has BMI ≥ 35 kg/m2. EX5: Is currently participating in another clinical trial with an investigational or noninvestigational drug or device, or was treated with an investigational drug within 28 days before the first vaccination. EX6: Has received, or plans to receive, any immunisation within 14 days of the start of the trial or during the trial immunisations. EX7: Is currently receiving treatment with systemic immunosuppressive agents. Topical steroids are allowed unless applied to the IM or ID injection site. EX8: Has a condition which in the opinion of the investigator is not suitable for participation in the trial. EX9: Is known or confirmed to have an allergy to any of the vaccine constituents. EX10: Is unable to refrain from the use of contact lenses. Contact lenses should be avoided two days before TO administration and for seven days later (longer if any ongoing local eye AE). EX11: Has any evident ocular disease upon ophthalmoscopic exam at screening or any medical history of ocular disease that, in the opinion of the investigator, may impact the subject's participation in the trial. EX12: Is pregnant (positive pregnancy test) or breastfeeding or not willing to use contraception during the trial. EX13: Has confirmed a history of pelvic inflammatory disease or significant gynaecological diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Solicited Local Injection Site Reactions | Visit 2 (Day 0) plus 14 Days | Local injection site reactions after intramuscular vaccination. Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth. |
| Solicited Local Ocular Reactions | Visit 4 (Day 28) plus 14 Days | Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort. |
| Solicited Systemic Reactions | Visit 2 (Day 0) plus 14 Days | Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity (4-fold Increase From Baseline) | Day 14, 28, 42, 56, 112, 126, 140, 154, 238 | Frequency of 4-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations. |
| Immunogenicity (10-fold Increase From Baseline) | Day 14, 28, 42, 56, 112, 126, 140, 154, 238 | Frequency of 10-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo given on Day 140. | 2 |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140. | 9 |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140. | 3 |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO unadjuvanted CTH522 given on Day 28, 112, and 140. | 9 |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO placebo given on Day 140. | 3 |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 Participants received 3 IM vaccinations of 85 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID unadjuvanted CTH522 given on Day 28 and 112 and TO unadjuvanted CTH522 given on Day 140. | 9 |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. | 3 |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 Participants received 3 IM vaccinations of 15 mcg CTH522-CAF01 (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140. | 9 |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. | 3 |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 Participants received 3 IM vaccinations of 85 mcg CTH522-CAF09b (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO unadjuvanted CTH522 on Day 140. | 9 |
| Cohort F1 IM Placebo + TO Placebo Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received TO placebo given on Day 28, 112, and 140. | 3 |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo Participants received 3 IM vaccinations of placebo (Day 0, 28, and 112). In addition, participants received ID placebo given on Day 28 and 112 and TO placebo on Day 140. | 3 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Cohort F1 IM Placebo + TO Placebo | Cohort F2 IM Placebo + ID Placebo + TO Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 3 Participants | 9 Participants | 3 Participants | 9 Participants | 3 Participants | 2 Participants | 9 Participants | 3 Participants | 9 Participants | 3 Participants | 3 Participants | 65 Participants |
| Age, Continuous | 26.9 years STANDARD_DEVIATION 6.4 | 21.7 years STANDARD_DEVIATION 2.1 | 28.4 years STANDARD_DEVIATION 7.3 | 32.3 years STANDARD_DEVIATION 6.1 | 22.4 years STANDARD_DEVIATION 2.4 | 25.7 years STANDARD_DEVIATION 9 | 22.0 years STANDARD_DEVIATION 1.4 | 26.8 years STANDARD_DEVIATION 5.6 | 31.7 years STANDARD_DEVIATION 8.5 | 30.1 years STANDARD_DEVIATION 9.9 | 24.7 years STANDARD_DEVIATION 5.5 | 25.0 years STANDARD_DEVIATION 5.3 | 26.8 years STANDARD_DEVIATION 6.8 |
| BMI | 24.78 kg/m2 STANDARD_DEVIATION 3.02 | 23.73 kg/m2 STANDARD_DEVIATION 2.25 | 22.62 kg/m2 STANDARD_DEVIATION 3.58 | 26.23 kg/m2 STANDARD_DEVIATION 2.55 | 23.63 kg/m2 STANDARD_DEVIATION 2.41 | 24.70 kg/m2 STANDARD_DEVIATION 1.55 | 20.70 kg/m2 STANDARD_DEVIATION 3.96 | 23.13 kg/m2 STANDARD_DEVIATION 1.67 | 21.70 kg/m2 STANDARD_DEVIATION 0.92 | 24.11 kg/m2 STANDARD_DEVIATION 3.55 | 24.37 kg/m2 STANDARD_DEVIATION 3.2 | 22.77 kg/m2 STANDARD_DEVIATION 0.55 | 23.64 kg/m2 STANDARD_DEVIATION 2.78 |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 1 participants | 0 participants | 3 participants | 0 participants | 0 participants | 1 participants | 1 participants | 1 participants | 0 participants | 0 participants | 8 participants |
| Race/Ethnicity, Customized Black or African American | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Other | 1 participants | 0 participants | 4 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants | 8 participants |
| Race/Ethnicity, Customized White | 6 participants | 3 participants | 4 participants | 3 participants | 6 participants | 3 participants | 1 participants | 6 participants | 1 participants | 7 participants | 3 participants | 3 participants | 46 participants |
| Region of Enrollment United Kingdom | 9 participants | 3 participants | 9 participants | 3 participants | 9 participants | 3 participants | 2 participants | 9 participants | 3 participants | 9 participants | 3 participants | 3 participants | 65 participants |
| Sex: Female, Male Female | 5 Participants | 1 Participants | 1 Participants | 1 Participants | 6 Participants | 2 Participants | 0 Participants | 5 Participants | 3 Participants | 5 Participants | 2 Participants | 3 Participants | 34 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 8 Participants | 2 Participants | 3 Participants | 1 Participants | 2 Participants | 4 Participants | 0 Participants | 4 Participants | 1 Participants | 0 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 9 | 0 / 3 | 0 / 9 | 0 / 3 | 0 / 9 | 0 / 3 | 0 / 9 | 0 / 3 | 0 / 9 | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 2 / 2 | 9 / 9 | 3 / 3 | 9 / 9 | 3 / 3 | 9 / 9 | 3 / 3 | 9 / 9 | 3 / 3 | 9 / 9 | 3 / 3 | 3 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 9 | 0 / 3 | 0 / 9 | 0 / 3 | 0 / 9 | 0 / 3 | 0 / 9 | 0 / 3 | 0 / 9 | 0 / 3 | 0 / 3 |
Outcome results
Primary
Solicited Local Injection Site Reactions
Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
Time frame: Visit 4 (Day 28) plus 14 Days
Population: Percentages calculated from number of participants vaccinated on Day 28.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 2 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 3 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 1 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 3 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 9 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 1 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 2 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 2 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 9 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 4 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 2 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 2 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 9 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 2 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 2 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 1 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 3 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 2 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 6 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 1 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 1 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 1 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 1 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 1 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 2 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 1 Participants |
Primary
Solicited Local Injection Site Reactions
Local injection site reactions after intramuscular vaccination (participants also received intradermal or topical ocular administration of CTH522 or placebo). Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
Time frame: Visit 7 (Day 112) plus 14 Days
Population: Percentages calculated from number of participants vaccinated on Day 112
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 1 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 1 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 2 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 6 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 1 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 1 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 1 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 2 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 8 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 2 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 1 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 1 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 1 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 2 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 2 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 6 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 3 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 5 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 3 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 8 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 1 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 1 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 2 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 7 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 2 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 1 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 3 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 3 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 1 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 3 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 8 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 1 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 1 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 2 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 1 Participants |
Primary
Solicited Local Injection Site Reactions
Local injection site reactions after intramuscular vaccination. Solicited local injection site reactions are defined as erythema, pruritus, pain, tenderness, swelling, and warmth.
Time frame: Visit 2 (Day 0) plus 14 Days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 2 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 1 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 1 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 1 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 3 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 3 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 9 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 2 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 2 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 1 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 9 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 1 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 1 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 1 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 4 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 3 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 2 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 9 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 1 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 1 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 3 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site erythema | 1 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pruritus | 1 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site swelling | 3 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site warmth | 2 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Injection Site Reactions | Injection site pain | 9 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site erythema | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site warmth | 1 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site swelling | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pain | 1 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Injection Site Reactions | Injection site pruritus | 0 Participants |
Comparison: Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs D \[D1, D2\].p-value: 1Fisher Exact
Comparison: Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs E \[E1, E2\].p-value: 1Fisher Exact
Comparison: Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs F \[F1, F2\].p-value: 0.0007Fisher Exact
Primary
Solicited Local Ocular Reactions
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
Time frame: Visit 9 (Day 140) plus 14 Days
Population: Percentages calculated from number of participants vaccinated on Day 140
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 2 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 3 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 3 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 2 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 1 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 1 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Ocular Reactions | Swelling of eyelid | 1 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Ocular Reactions | Swelling of eyelid | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 1 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 1 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Ocular Reactions | Swelling of eyelid | 1 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 2 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 3 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 1 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 1 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 1 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 1 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
Primary
Solicited Local Ocular Reactions
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
Time frame: Visit 4 (Day 28) plus 14 Days
Population: Percentages calculated from number of participants vaccinated on Day 28
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 1 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 1 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 1 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 1 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Ocular Reactions | Swelling of eyelid | 1 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 1 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 1 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 1 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Swelling of eyelid | 0 Participants |
Comparison: Comparison: Cohort B \[B1, B2\] vs A2.p-value: 1Fisher Exact
Comparison: Comparison: Cohort B \[B1, B2\] vs F1.p-value: 0.3956Fisher Exact
Primary
Solicited Local Ocular Reactions
Local ocular reactions after topical ocular administration of CTH522 or placebo. Solicited local ocular reactions are defined as watering eyes, swelling of eyelid, eye redness, and eye discomfort.
Time frame: Visit 7 (Day 112) plus 14 Days
Population: Percentages calculated from number of participants vaccinated on Day 112
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 1 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 1 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 1 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 1 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Lacrimation increased | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular discomfort | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Local Ocular Reactions | Ocular hyperaemia | 0 Participants |
Comparison: Comparison: Cohort B \[B1, B2\] vs A2.p-value: 1Fisher Exact
Comparison: Comparison: Cohort B \[B1, B2\] vs F1.p-value: 0.3956Fisher Exact
Primary
Solicited Systemic Reactions
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
Time frame: Visit 2 (Day 0) plus 14 Days
Population: Percentages calculated from number of participants vaccinated on Day 0
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Systemic Reactions | Chills | 1 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Systemic Reactions | Pyrexia | 1 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Systemic Reactions | Chills | 1 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Systemic Reactions | Rash | 1 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Systemic Reactions | Chills | 2 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Systemic Reactions | Pyrexia | 1 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Systemic Reactions | Myalgia | 2 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Rash | 1 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Chills | 2 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Systemic Reactions | Myalgia | 2 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Systemic Reactions | Rash | 0 Participants |
Comparison: Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs D \[D1, D2\].p-value: 1Fisher Exact
Comparison: Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs E \[E1, E2\].p-value: 1Fisher Exact
Comparison: Comparison: Cohort A-C \[A1, A2, B1, B2, C1, C2\] vs F \[F1, F2\].p-value: 0.3229Fisher Exact
Primary
Solicited Systemic Reactions
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
Time frame: Visit 4 (Day 28) plus 14 Days
Population: Percentages calculated from number of participants vaccinated on Day 28
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Systemic Reactions | Chills | 1 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Systemic Reactions | Myalgia | 3 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Systemic Reactions | Rash | 1 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Systemic Reactions | Chills | 1 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Systemic Reactions | Chills | 2 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Systemic Reactions | Chills | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Systemic Reactions | Pyrexia | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Rash | 1 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Systemic Reactions | Pyrexia | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Systemic Reactions | Rash | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Systemic Reactions | Chills | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Systemic Reactions | Pyrexia | 0 Participants |
Primary
Solicited Systemic Reactions
Systemic reactions after vaccinations. Solicited systemic reactions are defined as oral temperature \> 38.3°C, chills, myalgia, and rash.
Time frame: Visit 7 (Day 112) plus 14 Days
Population: Percentages calculated from number of participants vaccinated on Day 112
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Solicited Systemic Reactions | chills | 0 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Solicited Systemic Reactions | chills | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Solicited Systemic Reactions | chills | 0 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Solicited Systemic Reactions | chills | 1 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Systemic Reactions | chills | 1 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Systemic Reactions | Myalgia | 2 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Solicited Systemic Reactions | chills | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Systemic Reactions | chills | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Solicited Systemic Reactions | chills | 2 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Solicited Systemic Reactions | chills | 1 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Systemic Reactions | Myalgia | 1 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Solicited Systemic Reactions | chills | 2 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Systemic Reactions | chills | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Solicited Systemic Reactions | Myalgia | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Systemic Reactions | chills | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Solicited Systemic Reactions | Myalgia | 0 Participants |
Secondary
Immunogenicity (10-fold Increase From Baseline)
Frequency of 10-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.
Time frame: Day 14, 28, 42, 56, 112, 126, 140, 154, 238
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 112 | 1 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 14 | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 154 | 2 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 56 | 1 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 28 | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 238 | 1 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 140 | 2 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 42 | 1 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 126 | 2 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 112 | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 28 | 5 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 56 | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 154 | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 140 | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 42 | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 14 | 5 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 126 | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 238 | 8 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 238 | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 112 | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 42 | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 28 | 1 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 56 | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 154 | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 126 | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 140 | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 14 | 1 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 56 | 9 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 238 | 9 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 140 | 9 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 14 | 5 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 154 | 9 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 28 | 5 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 126 | 9 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 42 | 9 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 112 | 9 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 14 | 2 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 112 | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 56 | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 140 | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 126 | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 28 | 2 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 238 | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 42 | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 154 | 3 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 56 | 8 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 112 | 9 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 238 | 7 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 42 | 9 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 154 | 8 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 140 | 8 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 126 | 8 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 28 | 4 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 14 | 3 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 14 | 0 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 28 | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 56 | 3 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 238 | 2 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 140 | 2 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 42 | 3 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 112 | 2 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 154 | 2 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 126 | 2 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 42 | 8 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 154 | 9 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 238 | 8 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 14 | 0 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 28 | 1 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 56 | 9 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 112 | 8 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 126 | 9 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 140 | 9 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 238 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 14 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 126 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 28 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 42 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 140 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 154 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 112 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 56 | 3 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 56 | 8 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 42 | 8 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 154 | 8 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 112 | 8 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 28 | 6 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 14 | 6 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 126 | 8 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 238 | 8 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (10-fold Increase From Baseline) | Day 140 | 8 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 112 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 56 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 154 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 140 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 42 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 28 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 238 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 14 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 126 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 42 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 28 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 126 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 112 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 238 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 56 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 154 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 14 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (10-fold Increase From Baseline) | Day 140 | 0 Participants |
Secondary
Immunogenicity (4-fold Increase From Baseline)
Frequency of 4-fold increase seroconversion from baseline for anti-CTH522 IgG after vaccinations.
Time frame: Day 14, 28, 42, 56, 112, 126, 140, 154, 238
Population: Frequency of 4-fold increase seroconversion for anti-CTH522 IgG - full analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 238 | 2 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 56 | 2 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 126 | 2 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 28 | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 14 | 0 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 140 | 2 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 42 | 2 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 154 | 2 Participants |
| Cohort A1 85 mcg IM CTH522-CAF01 + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 112 | 1 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 112 | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 56 | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 14 | 6 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 238 | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 28 | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 42 | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 126 | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 154 | 8 Participants |
| Cohort A2 85 mcg IM CTH522-CAF01 + TO Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 140 | 8 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 14 | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 154 | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 140 | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 238 | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 56 | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 28 | 1 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 42 | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 126 | 2 Participants |
| Cohort B1 85 mcg IM CTH522-CAF01 + TO CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 112 | 2 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 42 | 9 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 126 | 9 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 154 | 9 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 238 | 9 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 112 | 9 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 140 | 9 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 56 | 9 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 14 | 7 Participants |
| Cohort B2 85 mcg IM CTH522-CAF01 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 28 | 6 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 154 | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 14 | 2 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 28 | 2 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 42 | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 238 | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 140 | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 56 | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 126 | 3 Participants |
| Cohort C1 85 mcg IM CTH522-CAF01 + ID CTH522 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 112 | 3 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 42 | 9 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 126 | 8 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 112 | 9 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 154 | 8 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 238 | 7 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 28 | 6 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 14 | 7 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 56 | 8 Participants |
| Cohort C2 85 mcg IM CTH522-CAF01 + ID CTH522 + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 140 | 8 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 112 | 2 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 28 | 2 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 42 | 3 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 56 | 3 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 14 | 1 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 126 | 2 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 140 | 2 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 154 | 2 Participants |
| Cohort D1 15 mcg IM CTH522-CAF01 + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 238 | 2 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 140 | 9 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 112 | 9 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 56 | 9 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 238 | 9 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 126 | 9 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 14 | 2 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 28 | 2 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 154 | 9 Participants |
| Cohort D2 15 mcg IM CTH522-CAF01 + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 42 | 9 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 56 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 238 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 126 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 140 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 42 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 28 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 154 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 14 | 3 Participants |
| Cohort E1 85 mcg IM CTH522-CAF09b + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 112 | 3 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 238 | 8 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 42 | 8 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 112 | 8 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 154 | 8 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 140 | 8 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 126 | 8 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 56 | 8 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 28 | 6 Participants |
| Cohort E2 85 mcg IM CTH522-CAF09b + ID Placebo + TO CTH522 | Immunogenicity (4-fold Increase From Baseline) | Day 14 | 7 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 154 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 140 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 28 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 238 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 126 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 112 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 14 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 56 | 0 Participants |
| Cohort F1 IM Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 42 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 112 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 28 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 140 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 42 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 238 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 126 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 154 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 14 | 0 Participants |
| Cohort F2 IM Placebo + ID Placebo + TO Placebo | Immunogenicity (4-fold Increase From Baseline) | Day 56 | 0 Participants |