Rotavirus Infection
Conditions
Keywords
rotavirus, vaccine
Brief summary
This study will evaluate 3 doses of a new vaccine for rotavirus infection in healthy adult volunteers to determine if it is safe and if the immune systems of healthy adults respond to this vaccine.
Detailed description
The trial will be a double-blinded, randomized, placebo-controlled dose-escalation study in which three dose-levels of vaccine will be tested in adults. Cohorts of 16 individuals (12 vaccine recipients and 4 placebo recipients) per dose level will receive three intramuscular injections four weeks apart. The three dose levels of vaccine to test will be 10 microgram (μg), 30 μg and 60 μg.
Interventions
BIOLOGICALP2-VP8 subunit rotavirus vaccine
P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration.
OTHERplacebo
Sodium Chloride 0.9%, USP for Injection was used to dilute the active P2-VP8 vaccine to final dosing concentration and was used for the Placebo for the study.
Sponsors
PATH
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
* A qualified volunteer must be: 1. Healthy male or female between 18 and 45 (inclusive) years of age at time of enrollment. 2. Willing and able to give informed consent - must pass test of comprehension with \> 70% correct within two attempts. 3. If female and of childbearing potential, be not breastfeeding and not pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to first injection), planning to avoid pregnancy for at least 4 weeks after the last injection, and willing to use an adequate method of contraception consistently and have repeated pregnancy tests prior to second and third injections. 4. Willing to comply with study restrictions and study schedule (as evidenced by a signed informed consent form (ICF) and assessment by the Principal Investigator (PI) or designee). 5. Able and willing to be contacted by telephone or text, and willing for study staff to record telephone voice or text messages as needed.
Exclusion criteria
* A qualified volunteer must not: 1. Have received an investigational product during the 30 days prior to randomization. 2. Intend to receive another investigational product during this study. 3. Have any contraindication to parenteral injections (e.g., history of bleeding disorder). 4. Have previously received a marketed or investigational rotavirus vaccine. 5. Have a history of severe local or systemic reaction to any vaccine. 6. Have a history of recurrent urticaria of unknown cause. 7. Have a history of any allergic or infusion reaction that was severe (e.g., anaphylactic or anaphylactoid), generalized (e.g., drug rash, urticaria, angioedema) or that, in the opinion of the PI, significantly increases risk of severe local or systemic reaction to an investigative vaccine. 8. Have a history of reaction to any vaccine that, in the opinion of the PI, significantly increases risk of severe reaction to an investigative vaccine. 9. Have received any vaccine within 4 weeks prior to randomization or planned vaccination through Day 84. 10. Have received any blood product or any immunomodulating agent (e.g., immunoglobulin, interferon, growth factor) within 12 weeks prior to randomization. 11. Have received immunosuppressive medications (e.g., prolonged use of systemic corticosteroid or cytotoxic agent) within the 24 weeks prior to randomization. Eligible if a short course (≤10 days) of systemic corticosteroid concluded more than 2 weeks prior to randomization, use of inhaled corticosteroid for asthma, and use of topical corticosteroid for a skin condition. 12. Have a history of any clinically significant (in the opinion of the PI) immunosuppressive or autoimmune condition. 13. Anticipate need for administration of any blood product, immunosuppressive (e.g., systemic corticosteroid), or immunomodulatory treatment during the study. 14. Have a history of malignancy, excluding basal cell carcinoma. 15. Have Diabetes Mellitus Type I or II. 16. Have a positive test for human immunodeficiency virus 1 (HIV-1), Hepatitis B surface antigen (HBsAg) or (Hepatitis C Antibody Test) anti-HepC. 17. Have significant abnormalities in screening laboratory test results or clinical assessment as determined by the PI or by the PI in consultation with the Sponsor's medical officer.\* 18. Have abnormal vital signs deemed clinically relevant by the Principle Investigator (PI). 19. Evidence of current or recent (within past 12 months) excessive alcohol consumption or drug dependence. 20. Have any condition of hand, arm or related lymph nodes that may confound post-dose assessments. 21. Have any condition (medical, psychiatric or behavioral) that, in the opinion of the PI, would increase the volunteer's health risks in study participation or would increase the risk of not achieving the study's objectives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Local or Systemic Reactogenicity After the Third Vaccination | 7 days post Vaccination #3 on Day 56 | For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination. Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy. |
| Maximum Severity of Adverse Events After Any Vaccination | 6 months after final vaccination (224 days) | Adverse events were collected through 28 days following the final study injection and were graded for severity. Unsolicited adverse events were also assessed for relationship to vaccine. A final follow-up contact was attempted 6 months following the final study injection to inquire about new chronic health conditions, serious health events, and hospitalizations. |
| Maximum Local or Systemic Reactogenicity After Any Vaccination | 7 days after each vaccination (Day 7, 35, 63) | For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination. Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy. |
| Maximum Local or Systemic Reactogenicity After the First Vaccination | 7 days post Vaccination #1 on Day 0 | For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination. Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy. |
| Maximum Local or Systemic Reactogenicity After the Second Vaccination | 7 days post Vaccination #2 on Day 35 | For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination. Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection) | Measured from sera taken on Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection). |
| Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection) | Measured from sera taken on Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection). |
| Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | 4 weeks post 3rd immunization (84 days) | Seroresponse was defined as as a four-fold increase in antibody titers between baseline and 4-weeks post-third injection. |
| Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | 4 weeks post 3rd immunization (84 days) | Seroresponse was defined as as a four-fold increase in antibody titers between baseline and 4-weeks post-third injection. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 10 μg P2-VP8 3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 10 μg of active ingredient.
P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration. | 12 |
| 30 μg P2-VP8 3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 30 μg of active ingredient.
P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration. | 12 |
| 60 μg P2-VP8 3 doses of P2-VP8 subunit rotavirus vaccine (Lot # 1746) produced in E. coli was adsorbed onto aluminum hydroxide (0.6 mg/dose) adjuvant prior to administration. Each dose contained 60 μg of active ingredient.
P2-VP8 subunit rotavirus vaccine: P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration. | 12 |
| Placebo 3 doses of placebo delivered intramuscularly.
placebo: Sodium Chloride 0.9%, USP for Injection was used to dilute the active P2-VP8 vaccine to final dosing concentration and was used for the Placebo for the study. | 12 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Completed Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Received All Vaccinations | Adverse Event | 1 | 1 | 0 | 0 |
| Received All Vaccinations | Did not meet inclusion criteria | 0 | 0 | 1 | 0 |
| Received All Vaccinations | Lost to Follow-up | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 10 μg P2-VP8 | 30 μg P2-VP8 | 60 μg P2-VP8 | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 29.6 years | 34.2 years | 33.8 years | 32.5 years | 32.5 years |
| Height | 172.7 centimeters | 173.1 centimeters | 168.8 centimeters | 171.9 centimeters | 171.6 centimeters |
| Region of Enrollment United States | 12 participants | 12 participants | 12 participants | 12 participants | 48 participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 6 Participants | 7 Participants | 25 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 6 Participants | 5 Participants | 23 Participants |
| Weight | 85.5 kilograms | 90.0 kilograms | 81.5 kilograms | 85.6 kilograms | 85.6 kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 9 / 12 | 5 / 12 | 7 / 12 | 6 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 1 / 12 | 0 / 12 |
Outcome results
Primary
Maximum Local or Systemic Reactogenicity After Any Vaccination
For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination. Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy.
Time frame: 7 days after each vaccination (Day 7, 35, 63)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Local reactogenicity | None | 7 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | All reactogenicity | None | 7 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Systemic reactogenicity | None | 10 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Local reactogenicity | Mild | 4 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | All reactogenicity | Moderate | 2 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Local reactogenicity | Moderate | 1 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | All reactogenicity | Mild | 3 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Systemic reactogenicity | Moderate | 1 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Systemic reactogenicity | Mild | 1 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Systemic reactogenicity | Moderate | 1 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | All reactogenicity | None | 3 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | All reactogenicity | Mild | 7 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | All reactogenicity | Moderate | 2 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Local reactogenicity | None | 4 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Local reactogenicity | Mild | 7 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Local reactogenicity | Moderate | 1 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Systemic reactogenicity | Mild | 7 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Systemic reactogenicity | None | 4 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | All reactogenicity | Mild | 6 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Systemic reactogenicity | None | 9 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Systemic reactogenicity | Mild | 3 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | All reactogenicity | Moderate | 0 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Systemic reactogenicity | Moderate | 0 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | All reactogenicity | None | 6 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Local reactogenicity | None | 7 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Local reactogenicity | Mild | 5 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After Any Vaccination | Local reactogenicity | Moderate | 0 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After Any Vaccination | All reactogenicity | Mild | 6 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After Any Vaccination | Local reactogenicity | Moderate | 1 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After Any Vaccination | Local reactogenicity | None | 4 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After Any Vaccination | Systemic reactogenicity | None | 6 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After Any Vaccination | All reactogenicity | Moderate | 2 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After Any Vaccination | Systemic reactogenicity | Moderate | 1 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After Any Vaccination | Local reactogenicity | Mild | 7 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After Any Vaccination | Systemic reactogenicity | Mild | 5 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After Any Vaccination | All reactogenicity | None | 4 Participants |
Comparison: Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)p-value: 0.5694Fisher Exact
Comparison: Proportion of subjects per Group with any Moderate or Higher Reaction (systemic reaction)p-value: 1Fisher Exact
Comparison: Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)p-value: 1Fisher Exact
Primary
Maximum Local or Systemic Reactogenicity After the First Vaccination
For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination. Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy.
Time frame: 7 days post Vaccination #1 on Day 0
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Systemic reactogenicity | Moderate | 1 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | All reactogenicity | Mild | 3 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | All reactogenicity | Moderate | 2 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Local reactogenicity | None | 7 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Local reactogenicity | Mild | 4 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Local reactogenicity | Moderate | 1 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Systemic reactogenicity | None | 11 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Systemic reactogenicity | Mild | 0 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | All reactogenicity | None | 7 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | All reactogenicity | None | 4 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | All reactogenicity | Mild | 8 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | All reactogenicity | Moderate | 0 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Local reactogenicity | None | 4 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Systemic reactogenicity | None | 8 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Local reactogenicity | Mild | 8 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Systemic reactogenicity | Mild | 4 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Systemic reactogenicity | Moderate | 0 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Local reactogenicity | Moderate | 0 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Systemic reactogenicity | Mild | 1 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Local reactogenicity | Moderate | 0 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | All reactogenicity | None | 8 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Local reactogenicity | None | 8 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | All reactogenicity | Mild | 4 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Local reactogenicity | Mild | 4 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | All reactogenicity | Moderate | 0 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Systemic reactogenicity | None | 11 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the First Vaccination | Systemic reactogenicity | Moderate | 0 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the First Vaccination | All reactogenicity | Moderate | 1 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the First Vaccination | Local reactogenicity | None | 5 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the First Vaccination | Local reactogenicity | Mild | 6 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the First Vaccination | Local reactogenicity | Moderate | 1 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the First Vaccination | Systemic reactogenicity | None | 7 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the First Vaccination | Systemic reactogenicity | Mild | 5 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the First Vaccination | Systemic reactogenicity | Moderate | 0 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the First Vaccination | All reactogenicity | None | 5 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the First Vaccination | All reactogenicity | Mild | 6 Participants |
Comparison: Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)p-value: 0.6004Fisher Exact
Comparison: Proportion of subjects per Group with any Moderate or Higher Reaction (systemic reaction)p-value: 1Fisher Exact
Comparison: Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)p-value: 1Fisher Exact
Primary
Maximum Local or Systemic Reactogenicity After the Second Vaccination
For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination. Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy.
Time frame: 7 days post Vaccination #2 on Day 35
Population: 47 subjects received the second vaccination (one less than Analysis Population Description). Subject in the placebo group withdrew Completed vaccination # 1 but withdrew due to moderate pain, tenderness and swelling, before Vaccination 2.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Systemic reactogenicity | Moderate | 0 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Local reactogenicity | Moderate | 0 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Local reactogenicity | Mild | 0 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Local reactogenicity | None | 11 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | All reactogenicity | Mild | 1 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | All reactogenicity | None | 10 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Systemic reactogenicity | Mild | 1 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Systemic reactogenicity | None | 10 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | All reactogenicity | Moderate | 0 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Local reactogenicity | None | 7 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | All reactogenicity | None | 6 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | All reactogenicity | Mild | 5 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | All reactogenicity | Moderate | 1 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Local reactogenicity | Mild | 4 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Local reactogenicity | Moderate | 1 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Systemic reactogenicity | None | 9 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Systemic reactogenicity | Mild | 3 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Systemic reactogenicity | Moderate | 0 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Local reactogenicity | Mild | 3 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | All reactogenicity | Moderate | 0 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | All reactogenicity | None | 9 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Local reactogenicity | Moderate | 0 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Systemic reactogenicity | Moderate | 0 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Systemic reactogenicity | None | 12 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | All reactogenicity | Mild | 3 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Systemic reactogenicity | Mild | 0 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Local reactogenicity | None | 9 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Second Vaccination | All reactogenicity | Moderate | 0 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Systemic reactogenicity | Moderate | 0 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Second Vaccination | All reactogenicity | Mild | 4 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Second Vaccination | All reactogenicity | None | 8 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Systemic reactogenicity | Mild | 1 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Local reactogenicity | Moderate | 0 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Local reactogenicity | Mild | 4 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Local reactogenicity | None | 8 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Second Vaccination | Systemic reactogenicity | None | 11 Participants |
Comparison: Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)p-value: 1Fisher Exact
Comparison: Proportion of subjects per Group with any Moderate or Higher Reaction (systemic)p-value: 1Fisher Exact
Comparison: Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)p-value: 1Fisher Exact
Primary
Maximum Local or Systemic Reactogenicity After the Third Vaccination
For all cohorts, local and systemic reactogenicity data for all vaccinations were collected by subjects via diary card up to 7 days post each vaccination. Solicited systemic reactogenicity events included headache, muscle pain, fever, nausea, vomiting, fatigue, joint aches, and chills. Solicited local systemic reactogenicity events included injection site pain, tenderness, redness, swelling, itching, and local lymphadenopathy.
Time frame: 7 days post Vaccination #3 on Day 56
Population: 44 subjects received third vaccination (4 less than Analysis Population Description). 2 subjects lost in Placebo group, one due to pain, swelling (after vaccination #2) and 1 due to incarceration. 1 subject lost from 10 μg cohort due to illness, 1 subject lost in 30 μg cohort because did not continue to meet inclusion/exclusion criteria.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | All reactogenicity | None | 9 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | All reactogenicity | Mild | 1 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | All reactogenicity | Moderate | 0 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Local reactogenicity | None | 10 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Local reactogenicity | Moderate | 0 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Systemic reactogenicity | None | 9 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Systemic reactogenicity | Mild | 1 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Systemic reactogenicity | Moderate | 0 Participants |
| 10 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Local reactogenicity | Mild | 0 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | All reactogenicity | None | 7 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Systemic reactogenicity | None | 8 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Local reactogenicity | Moderate | 0 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Local reactogenicity | None | 8 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Systemic reactogenicity | Moderate | 1 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | All reactogenicity | Moderate | 1 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Systemic reactogenicity | Mild | 2 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Local reactogenicity | Mild | 3 Participants |
| 30 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | All reactogenicity | Mild | 3 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Systemic reactogenicity | Mild | 2 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | All reactogenicity | Moderate | 0 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Local reactogenicity | None | 10 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Local reactogenicity | Mild | 1 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Local reactogenicity | Moderate | 0 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Systemic reactogenicity | None | 9 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Systemic reactogenicity | Moderate | 0 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | All reactogenicity | None | 9 Participants |
| 60 μg P2-VP8 | Maximum Local or Systemic Reactogenicity After the Third Vaccination | All reactogenicity | Mild | 2 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Third Vaccination | All reactogenicity | Moderate | 1 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Local reactogenicity | Mild | 4 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Third Vaccination | All reactogenicity | Mild | 3 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Third Vaccination | All reactogenicity | None | 8 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Local reactogenicity | None | 8 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Local reactogenicity | Moderate | 0 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Systemic reactogenicity | Moderate | 1 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Systemic reactogenicity | Mild | 2 Participants |
| Placebo | Maximum Local or Systemic Reactogenicity After the Third Vaccination | Systemic reactogenicity | None | 9 Participants |
Comparison: Proportion of subjects per Group with any Moderate or Higher Reaction (systemic or local reaction)p-value: 1Fisher Exact
Comparison: Proportion of subjects per Group with any Moderate or Higher Reaction (systemic)p-value: 1Fisher Exact
Comparison: Proportion of subjects per Group with any Moderate or Higher Reaction (local reaction)p-value: 1Fisher Exact
Primary
Maximum Severity of Adverse Events After Any Vaccination
Adverse events were collected through 28 days following the final study injection and were graded for severity. Unsolicited adverse events were also assessed for relationship to vaccine. A final follow-up contact was attempted 6 months following the final study injection to inquire about new chronic health conditions, serious health events, and hospitalizations.
Time frame: 6 months after final vaccination (224 days)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 10 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | Mild | 1 Participants |
| 10 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | Moderate | 0 Participants |
| 10 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | Severe | 0 Participants |
| 10 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | None | 11 Participants |
| 10 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | Mild | 6 Participants |
| 10 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | Moderate | 3 Participants |
| 10 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | Severe | 0 Participants |
| 10 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | None | 3 Participants |
| 30 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | Mild | 2 Participants |
| 30 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | Mild | 2 Participants |
| 30 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | None | 7 Participants |
| 30 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | Severe | 0 Participants |
| 30 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | Moderate | 3 Participants |
| 30 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | None | 9 Participants |
| 30 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | Severe | 0 Participants |
| 30 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | Moderate | 1 Participants |
| 60 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | Moderate | 0 Participants |
| 60 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | Severe | 1 Participants |
| 60 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | Mild | 0 Participants |
| 60 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | Mild | 6 Participants |
| 60 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | Moderate | 0 Participants |
| 60 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | None | 5 Participants |
| 60 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | None | 12 Participants |
| 60 μg P2-VP8 | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | Severe | 0 Participants |
| Placebo | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | Moderate | 0 Participants |
| Placebo | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | None | 6 Participants |
| Placebo | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | None | 10 Participants |
| Placebo | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | Moderate | 1 Participants |
| Placebo | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | Severe | 0 Participants |
| Placebo | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | Severe | 0 Participants |
| Placebo | Maximum Severity of Adverse Events After Any Vaccination | All adverse events | Mild | 5 Participants |
| Placebo | Maximum Severity of Adverse Events After Any Vaccination | Possibly related to vaccine | Mild | 2 Participants |
Comparison: Proportion of subjects with at least one unsolicited adverse event: potentially relatedp-value: 0.7446Fisher Exact
Comparison: Proportion of subjects with at least one unsolicited adverse event (related or unrelated)p-value: 0.44Fisher Exact
Secondary
Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA)
Measured from sera taken on Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection).
Time frame: Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection)
Population: Included subjects that received vaccinations (see participant flow for reasons why some subjects did not receive all vaccinations).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | Baseline | 519 titer |
| 10 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | Pre-vaccination 3 | 513 titer |
| 10 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | 4 weeks post-vaccination 3 | 520 titer |
| 10 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | Pre-vaccination 2 | 551 titer |
| 30 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | Pre-vaccination 3 | 7373 titer |
| 30 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | Pre-vaccination 2 | 2607 titer |
| 30 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | Baseline | 362 titer |
| 30 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | 4 weeks post-vaccination 3 | 13090 titer |
| 60 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | Pre-vaccination 2 | 4314 titer |
| 60 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | Pre-vaccination 3 | 8489 titer |
| 60 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | Baseline | 457 titer |
| 60 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | 4 weeks post-vaccination 3 | 13932 titer |
| Placebo | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | Pre-vaccination 2 | 2867 titer |
| Placebo | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | 4 weeks post-vaccination 3 | 19546 titer |
| Placebo | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | Pre-vaccination 3 | 12438 titer |
| Placebo | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin A (IgA) | Baseline | 285 titer |
Secondary
Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG)
Measured from sera taken on Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection).
Time frame: Days 0, 28, 56 and 84 (before the first injection and 4 weeks after each injection)
Population: Included subjects that received vaccinations (see participant flow for reasons why some subjects did not receive all vaccinations).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 10 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | Baseline | 519 titer |
| 10 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | Pre-vaccination 3 | 513 titer |
| 10 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | 4 weeks post-vaccination 3 | 520 titer |
| 10 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | Pre-vaccination 2 | 551 titer |
| 30 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | Pre-vaccination 3 | 7373 titer |
| 30 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | Pre-vaccination 2 | 2607 titer |
| 30 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | Baseline | 362 titer |
| 30 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | 4 weeks post-vaccination 3 | 13090 titer |
| 60 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | Pre-vaccination 2 | 4314 titer |
| 60 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | Pre-vaccination 3 | 8489 titer |
| 60 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | Baseline | 457 titer |
| 60 μg P2-VP8 | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | 4 weeks post-vaccination 3 | 13932 titer |
| Placebo | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | Pre-vaccination 2 | 2867 titer |
| Placebo | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | 4 weeks post-vaccination 3 | 19546 titer |
| Placebo | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | Pre-vaccination 3 | 12438 titer |
| Placebo | Geometric Mean Titer (GMT) of Anti-P2-VP8 Immunoglobulin G (IgG) | Baseline | 285 titer |
Secondary
Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses
Seroresponse was defined as as a four-fold increase in antibody titers between baseline and 4-weeks post-third injection.
Time frame: 4 weeks post 3rd immunization (84 days)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 10 μg P2-VP8 | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgG | Seroresponse | 0 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgG | No seroresponse | 11 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgA | Seroresponse | 0 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgA | No seroresponse | 11 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgG | No seroresponse | 0 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgA | Seroresponse | 12 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgA | No seroresponse | 0 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgG | Seroresponse | 12 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgA | Seroresponse | 12 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgG | No seroresponse | 1 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgA | No seroresponse | 0 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgG | Seroresponse | 11 Participants |
| Placebo | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgA | No seroresponse | 0 Participants |
| Placebo | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgG | No seroresponse | 0 Participants |
| Placebo | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgG | Seroresponse | 12 Participants |
| Placebo | Number and Percentage of Subjects With Anti-P2-VP8 Immunoglobulin G (IgG) and Immunoglobulin A (IgA) Seroresponses | IgA | Seroresponse | 12 Participants |
Secondary
Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain
Seroresponse was defined as as a four-fold increase in antibody titers between baseline and 4-weeks post-third injection.
Time frame: 4 weeks post 3rd immunization (84 days)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | DS1 | Seroresponse | 0 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | WA | No seroresponse | 4 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | 89-12 | Seroresponse | 10 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | 89-12 | No seroresponse | 2 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | WA | Seroresponse | 8 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | DS1 | No seroresponse | 12 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | P | Seroresponse | 7 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | P | No seroresponse | 5 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | ST3 | Seroresponse | 0 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | ST3 | No seroresponse | 12 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | BRB | Seroresponse | 0 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | SC2 | Seroresponse | 1 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | SC2 | No seroresponse | 11 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | W161 | Seroresponse | 8 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | W161 | No seroresponse | 4 Participants |
| 10 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | BRB | No seroresponse | 12 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | DS1 | No seroresponse | 6 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | P | Seroresponse | 8 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | P | No seroresponse | 4 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | W161 | Seroresponse | 9 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | ST3 | Seroresponse | 1 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | ST3 | No seroresponse | 11 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | BRB | No seroresponse | 9 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | BRB | Seroresponse | 3 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | WA | Seroresponse | 5 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | W161 | No seroresponse | 3 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | WA | No seroresponse | 7 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | SC2 | Seroresponse | 4 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | 89-12 | Seroresponse | 8 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | 89-12 | No seroresponse | 4 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | DS1 | Seroresponse | 6 Participants |
| 30 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | SC2 | No seroresponse | 8 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | BRB | Seroresponse | 4 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | DS1 | No seroresponse | 5 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | SC2 | No seroresponse | 8 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | 89-12 | Seroresponse | 10 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | P | Seroresponse | 10 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | BRB | No seroresponse | 8 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | WA | Seroresponse | 7 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | P | No seroresponse | 2 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | SC2 | Seroresponse | 4 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | DS1 | Seroresponse | 7 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | ST3 | Seroresponse | 2 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | W161 | Seroresponse | 10 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | WA | No seroresponse | 5 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | ST3 | No seroresponse | 10 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | 89-12 | No seroresponse | 2 Participants |
| 60 μg P2-VP8 | Number and Percentage of Subjects With Serum Neutralizing Antibody Seroresponse, by Rotavirus Strain | W161 | No seroresponse | 2 Participants |