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Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients

A Multicenter, Open-label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA-BN® (IMVAMUNE) Smallpox Vaccine in 18-55 Year Old Naive and Previously Vaccinated HIV Infected Subjects With CD4 Counts >200 - 750/µl.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00316589
Enrollment
581
Registered
2006-04-21
Start date
2006-06-30
Completion date
2009-10-31
Last updated
2019-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV, treatment experienced, treatment vaccinia naive

Brief summary

The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations

Interventions

BIOLOGICALIMVAMUNE (MVA-BN)

2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Bavarian Nordic
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Genders eligible for Study: Both * Age: between 18 and 55 years * Healthy volunteers are accepted Inclusion Criteria: * Subjects tested positive for HIV-1 infection (HIV-infected subjects). * Subjects that are tested negative for HIV (Healthy subjects). * Either on stable antiretroviral therapy or not on antiretroviral therapy. * CD4 cells \> = 200 - 750/µl. * Subjects must be in good general health except for HIV infection. * Women must not be pregnant and use an acceptable method of contraception.

Exclusion criteria

* Impairment of immunologic function (other than HIV infection). * History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure. * Uncontrolled serious infection. * History of or active autoimmune disease. * History or clinical manifestation of clinically significant and severe hematological, renal, hepatic, pulmonary, central nervous, cardiovascular or gastrointestinal disorders. * History of an immediate family member (father, mother, brother, or sister) who has had onset of ischemic heart disease before the age of 50 years. * High risk of developing a myocardial infarction or coronary death. * History of intravenous drug abuse (within the last 12 months). * Known allergy to egg or aminoglycoside (gentamicin). * History of anaphylaxis or severe allergic reaction. * Subjects undergoing treatment for tuberculosis infection or disease. * Chronic administration of systemic immuno-suppressants.

Design outcomes

Primary

MeasureTime frameDescription
Serious Adverse Eventswithin 32 weeksIncidence, relationship and intensity of any Serious Adverse Event (SAE)

Secondary

MeasureTime frameDescription
Solicited Local Adverse Eventswithin 8 days after any vaccinationIncidence and intensity of solicited local AEs (pain, erythema, swelling). Percentages based on subjects with at least one completed diary card.
Solicited General Adverse Eventswithin 8 days after any vaccinationIncidence of solicited general AEs (increased body temperature, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
Unsolicited Adverse Events: Incidencewithin 29 days after any vaccinationIncidence of any unsolicited adverse events
Unsolicited Adverse Events: Intensitywithin 29 days after any vaccinationOccurrence of unsolicited adverse events by Intensity
Unsolicited Adverse Events: Relationship to Vaccinationwithin 29 days after any vaccinationOccurrence of unsolicited adverse events by relationship to study vaccine
CD4+ T-cell Countswithin 32 weeksMedian CD4+ T-cell counts over time
CD8+ T-cell Countswithin 32 weeksMedian CD8+ T-cell counts over time
Related Grade >=3 Adverse Eventswithin 29 days after any vaccinationIncidence of any Grade 3 or higher adverse drug reaction (missing, unknown, not evaluable, possibly, probably, or definitely related) to the study vaccine
PRNT Seroconversion Ratewithin 32 weeksSeroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
PRNT GMTwithin 32 weeksGeometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
ELISA Seroconversion Ratewithin 32 weeksSeroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
ELISA GMTwithin 32 weeksGeometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.
ELISPOT IFN-γ: Response Ratewithin 32 weeksResponse rate based on number of subjects with response in an interferon gamma (IFN-γ) ELISPOT assay. Response is defined as the appearance of a signal in subjects that had no signal at Baseline or a relative increase by a factor of ≥1.7 compared to Baseline in subjects that had a signal at Baseline. Percentages based on number of subjects with data available.
ELISPOT IFN-γ: SFUwithin 32 weeksMedian number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) in response to stimulation with MVA-BN detected by ELISPOT assay.
Viral Loadwithin 32 weeksViral load (HIV-1 RNA levels) over time

Countries

Puerto Rico, United States

Participant flow

Participants by arm

ArmCount
Healthy naïve
Healthy, smallpox vaccine-naïve subjects
88
HIV naïve
HIV-infected, smallpox vaccine-naïve subjects
351
Healthy Experienced
Healthy, smallpox vaccine-experienced subjects
9
HIV Experienced
HIV-infected, smallpox vaccine-experienced subjects
131
Total579

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyAdverse Event1001
Overall StudyOther reason01211
Overall StudyPhysician Decision0100
Overall StudySubject unwilling/unable to comply0602
Overall StudyWithdrawal by Subject0501

Baseline characteristics

CharacteristicHealthy naïveHIV naïveHealthy ExperiencedHIV ExperiencedTotal
Age, Continuous28.9 years
STANDARD_DEVIATION 7.14
36.8 years
STANDARD_DEVIATION 7.98
45.6 years
STANDARD_DEVIATION 8.88
44.6 years
STANDARD_DEVIATION 5.13
37.5 years
STANDARD_DEVIATION 8.8
Region of Enrollment
Puerto Rico
0 participants27 participants0 participants7 participants34 participants
Region of Enrollment
United States
88 participants324 participants9 participants124 participants545 participants
Sex: Female, Male
Female
50 Participants64 Participants4 Participants21 Participants139 Participants
Sex: Female, Male
Male
38 Participants287 Participants5 Participants110 Participants440 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 881 / 3510 / 90 / 131
other
Total, other adverse events
51 / 88172 / 3513 / 945 / 131
serious
Total, serious adverse events
0 / 8817 / 3510 / 96 / 131

Outcome results

Primary

Serious Adverse Events

Incidence, relationship and intensity of any Serious Adverse Event (SAE)

Time frame: within 32 weeks

Population: Full Analysis Set

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Healthy naïveSerious Adverse EventsAny SAE0 Participants
Healthy naïveSerious Adverse EventsAny SAE assessed as related to vaccine0 Participants
Healthy naïveSerious Adverse EventsAny SAE with intensity >= Grade 30 Participants
HIV naïveSerious Adverse EventsAny SAE17 Participants
HIV naïveSerious Adverse EventsAny SAE assessed as related to vaccine1 Participants
HIV naïveSerious Adverse EventsAny SAE with intensity >= Grade 315 Participants
Healthy ExperiencedSerious Adverse EventsAny SAE with intensity >= Grade 30 Participants
Healthy ExperiencedSerious Adverse EventsAny SAE0 Participants
Healthy ExperiencedSerious Adverse EventsAny SAE assessed as related to vaccine0 Participants
HIV ExperiencedSerious Adverse EventsAny SAE6 Participants
HIV ExperiencedSerious Adverse EventsAny SAE assessed as related to vaccine0 Participants
HIV ExperiencedSerious Adverse EventsAny SAE with intensity >= Grade 35 Participants
Secondary

CD4+ T-cell Counts

Median CD4+ T-cell counts over time

Time frame: within 32 weeks

Population: Full Analysis Set (HIV infected subjects)

ArmMeasureGroupValue (MEDIAN)
Healthy naïveCD4+ T-cell CountsWeek 0445.0 CD4 count (cells/µL)
Healthy naïveCD4+ T-cell CountsWeek 1434.5 CD4 count (cells/µL)
Healthy naïveCD4+ T-cell CountsWeek 6438.5 CD4 count (cells/µL)
Healthy naïveCD4+ T-cell CountsWeek 32403.5 CD4 count (cells/µL)
HIV naïveCD4+ T-cell CountsWeek 32435.0 CD4 count (cells/µL)
HIV naïveCD4+ T-cell CountsWeek 0456.0 CD4 count (cells/µL)
HIV naïveCD4+ T-cell CountsWeek 6447.0 CD4 count (cells/µL)
HIV naïveCD4+ T-cell CountsWeek 1455.0 CD4 count (cells/µL)
Secondary

CD8+ T-cell Counts

Median CD8+ T-cell counts over time

Time frame: within 32 weeks

Population: Full Analysis Set (HIV infected subjects)

ArmMeasureGroupValue (MEDIAN)
Healthy naïveCD8+ T-cell CountsWeek 0771.0 CD8 count (cells/µL)
Healthy naïveCD8+ T-cell CountsWeek 1779.0 CD8 count (cells/µL)
Healthy naïveCD8+ T-cell CountsWeek 6749.0 CD8 count (cells/µL)
Healthy naïveCD8+ T-cell CountsWeek 32834.0 CD8 count (cells/µL)
HIV naïveCD8+ T-cell CountsWeek 32729.0 CD8 count (cells/µL)
HIV naïveCD8+ T-cell CountsWeek 0877.5 CD8 count (cells/µL)
HIV naïveCD8+ T-cell CountsWeek 6798.5 CD8 count (cells/µL)
HIV naïveCD8+ T-cell CountsWeek 1848.0 CD8 count (cells/µL)
Secondary

ELISA GMT

Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.

Time frame: within 32 weeks

Population: Per-protocol Set

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Healthy naïveELISA GMTWeek 8312.9 Titer
Healthy naïveELISA GMTWeek 456.2 Titer
Healthy naïveELISA GMTWeek 6526.2 Titer
Healthy naïveELISA GMTWeek 01.9 Titer
Healthy naïveELISA GMTWeek 3232.1 Titer
Healthy naïveELISA GMTWeek 13.7 Titer
HIV naïveELISA GMTWeek 8175.5 Titer
HIV naïveELISA GMTWeek 446.6 Titer
HIV naïveELISA GMTWeek 04.6 Titer
HIV naïveELISA GMTWeek 19.4 Titer
HIV naïveELISA GMTWeek 6299.8 Titer
HIV naïveELISA GMTWeek 3224.3 Titer
Healthy ExperiencedELISA GMTWeek 1260.6 Titer
Healthy ExperiencedELISA GMTWeek 3289.5 Titer
Healthy ExperiencedELISA GMTWeek 037.1 Titer
Healthy ExperiencedELISA GMTWeek 4461.1 Titer
Healthy ExperiencedELISA GMTWeek 6612.9 Titer
Healthy ExperiencedELISA GMTWeek 8403.4 Titer
HIV ExperiencedELISA GMTWeek 6588.4 Titer
HIV ExperiencedELISA GMTWeek 32203.9 Titer
HIV ExperiencedELISA GMTWeek 033.3 Titer
HIV ExperiencedELISA GMTWeek 189.9 Titer
HIV ExperiencedELISA GMTWeek 4220.1 Titer
HIV ExperiencedELISA GMTWeek 8453.1 Titer
Secondary

ELISA Seroconversion Rate

Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.

Time frame: within 32 weeks

Population: Per-protocol set

ArmMeasureGroupValue (NUMBER)
Healthy naïveELISA Seroconversion RateWeek 698.2 percentage of subjects
Healthy naïveELISA Seroconversion RateWeek 124.6 percentage of subjects
Healthy naïveELISA Seroconversion RateWeek 896.5 percentage of subjects
Healthy naïveELISA Seroconversion RateWeek 3266.7 percentage of subjects
Healthy naïveELISA Seroconversion RateWeek 480.7 percentage of subjects
HIV naïveELISA Seroconversion RateWeek 3246.4 percentage of subjects
HIV naïveELISA Seroconversion RateWeek 129.5 percentage of subjects
HIV naïveELISA Seroconversion RateWeek 697.1 percentage of subjects
HIV naïveELISA Seroconversion RateWeek 469.3 percentage of subjects
HIV naïveELISA Seroconversion RateWeek 892.1 percentage of subjects
Healthy ExperiencedELISA Seroconversion RateWeek 6100.0 percentage of subjects
Healthy ExperiencedELISA Seroconversion RateWeek 4100.0 percentage of subjects
Healthy ExperiencedELISA Seroconversion RateWeek 180.0 percentage of subjects
Healthy ExperiencedELISA Seroconversion RateWeek 8100.0 percentage of subjects
Healthy ExperiencedELISA Seroconversion RateWeek 3260.0 percentage of subjects
HIV ExperiencedELISA Seroconversion RateWeek 890.1 percentage of subjects
HIV ExperiencedELISA Seroconversion RateWeek 3276.5 percentage of subjects
HIV ExperiencedELISA Seroconversion RateWeek 479.1 percentage of subjects
HIV ExperiencedELISA Seroconversion RateWeek 158.2 percentage of subjects
HIV ExperiencedELISA Seroconversion RateWeek 694.5 percentage of subjects
Secondary

ELISPOT IFN-γ: Response Rate

Response rate based on number of subjects with response in an interferon gamma (IFN-γ) ELISPOT assay. Response is defined as the appearance of a signal in subjects that had no signal at Baseline or a relative increase by a factor of ≥1.7 compared to Baseline in subjects that had a signal at Baseline. Percentages based on number of subjects with data available.

Time frame: within 32 weeks

Population: Elispot Analysis Set (subset of the Per-protocol Set with ELISPOT data available)

ArmMeasureGroupValue (NUMBER)
Healthy naïveELISPOT IFN-γ: Response RateWeek 139.1 percentage of subjects
Healthy naïveELISPOT IFN-γ: Response RateWeek 439.1 percentage of subjects
Healthy naïveELISPOT IFN-γ: Response RateWeek 647.8 percentage of subjects
Healthy naïveELISPOT IFN-γ: Response RateWeek 830.4 percentage of subjects
Healthy naïveELISPOT IFN-γ: Response RateWeek 3252.4 percentage of subjects
HIV naïveELISPOT IFN-γ: Response RateWeek 3236.8 percentage of subjects
HIV naïveELISPOT IFN-γ: Response RateWeek 640.0 percentage of subjects
HIV naïveELISPOT IFN-γ: Response RateWeek 128.6 percentage of subjects
HIV naïveELISPOT IFN-γ: Response RateWeek 420.0 percentage of subjects
HIV naïveELISPOT IFN-γ: Response RateWeek 825.7 percentage of subjects
Healthy ExperiencedELISPOT IFN-γ: Response RateWeek 3250.0 percentage of subjects
Healthy ExperiencedELISPOT IFN-γ: Response RateWeek 80.0 percentage of subjects
Healthy ExperiencedELISPOT IFN-γ: Response RateWeek 60.0 percentage of subjects
Healthy ExperiencedELISPOT IFN-γ: Response RateWeek 10.0 percentage of subjects
Healthy ExperiencedELISPOT IFN-γ: Response RateWeek 433.3 percentage of subjects
HIV ExperiencedELISPOT IFN-γ: Response RateWeek 429.4 percentage of subjects
HIV ExperiencedELISPOT IFN-γ: Response RateWeek 126.5 percentage of subjects
HIV ExperiencedELISPOT IFN-γ: Response RateWeek 3223.1 percentage of subjects
HIV ExperiencedELISPOT IFN-γ: Response RateWeek 629.4 percentage of subjects
HIV ExperiencedELISPOT IFN-γ: Response RateWeek 829.4 percentage of subjects
Secondary

ELISPOT IFN-γ: SFU

Median number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) in response to stimulation with MVA-BN detected by ELISPOT assay.

Time frame: within 32 weeks

Population: Elispot Analysis Set (subset of the Per-protocol Set with ELISPOT data available)

ArmMeasureGroupValue (MEDIAN)
Healthy naïveELISPOT IFN-γ: SFUWeek 493.0 Spot Forming Units / 10^6 PBMC
Healthy naïveELISPOT IFN-γ: SFUWeek 00.0 Spot Forming Units / 10^6 PBMC
Healthy naïveELISPOT IFN-γ: SFUWeek 80.0 Spot Forming Units / 10^6 PBMC
Healthy naïveELISPOT IFN-γ: SFUWeek 187.0 Spot Forming Units / 10^6 PBMC
Healthy naïveELISPOT IFN-γ: SFUWeek 699.0 Spot Forming Units / 10^6 PBMC
Healthy naïveELISPOT IFN-γ: SFUWeek 3271.0 Spot Forming Units / 10^6 PBMC
HIV naïveELISPOT IFN-γ: SFUWeek 80.0 Spot Forming Units / 10^6 PBMC
HIV naïveELISPOT IFN-γ: SFUWeek 3273.0 Spot Forming Units / 10^6 PBMC
HIV naïveELISPOT IFN-γ: SFUWeek 40.0 Spot Forming Units / 10^6 PBMC
HIV naïveELISPOT IFN-γ: SFUWeek 00.0 Spot Forming Units / 10^6 PBMC
HIV naïveELISPOT IFN-γ: SFUWeek 10.0 Spot Forming Units / 10^6 PBMC
HIV naïveELISPOT IFN-γ: SFUWeek 672.0 Spot Forming Units / 10^6 PBMC
Healthy ExperiencedELISPOT IFN-γ: SFUWeek 32596.0 Spot Forming Units / 10^6 PBMC
Healthy ExperiencedELISPOT IFN-γ: SFUWeek 171.0 Spot Forming Units / 10^6 PBMC
Healthy ExperiencedELISPOT IFN-γ: SFUWeek 871.0 Spot Forming Units / 10^6 PBMC
Healthy ExperiencedELISPOT IFN-γ: SFUWeek 4569.0 Spot Forming Units / 10^6 PBMC
Healthy ExperiencedELISPOT IFN-γ: SFUWeek 654.0 Spot Forming Units / 10^6 PBMC
Healthy ExperiencedELISPOT IFN-γ: SFUWeek 0155.0 Spot Forming Units / 10^6 PBMC
HIV ExperiencedELISPOT IFN-γ: SFUWeek 320.0 Spot Forming Units / 10^6 PBMC
HIV ExperiencedELISPOT IFN-γ: SFUWeek 853.0 Spot Forming Units / 10^6 PBMC
HIV ExperiencedELISPOT IFN-γ: SFUWeek 10.0 Spot Forming Units / 10^6 PBMC
HIV ExperiencedELISPOT IFN-γ: SFUWeek 00.0 Spot Forming Units / 10^6 PBMC
HIV ExperiencedELISPOT IFN-γ: SFUWeek 657.5 Spot Forming Units / 10^6 PBMC
HIV ExperiencedELISPOT IFN-γ: SFUWeek 40.0 Spot Forming Units / 10^6 PBMC
Secondary

PRNT GMT

Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.

Time frame: within 32 weeks

Population: Per-protocol Set

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Healthy naïvePRNT GMTWeek 11.6 Titer
Healthy naïvePRNT GMTWeek 620.8 Titer
Healthy naïvePRNT GMTWeek 42.1 Titer
Healthy naïvePRNT GMTWeek 322.8 Titer
Healthy naïvePRNT GMTWeek 814.8 Titer
Healthy naïvePRNT GMTWeek 01.3 Titer
HIV naïvePRNT GMTWeek 89.7 Titer
HIV naïvePRNT GMTWeek 12.9 Titer
HIV naïvePRNT GMTWeek 323.3 Titer
HIV naïvePRNT GMTWeek 43.7 Titer
HIV naïvePRNT GMTWeek 02.0 Titer
HIV naïvePRNT GMTWeek 613.0 Titer
Healthy ExperiencedPRNT GMTWeek 1108.9 Titer
Healthy ExperiencedPRNT GMTWeek 012.0 Titer
Healthy ExperiencedPRNT GMTWeek 8171.2 Titer
Healthy ExperiencedPRNT GMTWeek 3258.0 Titer
Healthy ExperiencedPRNT GMTWeek 6354.5 Titer
Healthy ExperiencedPRNT GMTWeek 4100.2 Titer
HIV ExperiencedPRNT GMTWeek 3253.1 Titer
HIV ExperiencedPRNT GMTWeek 05.5 Titer
HIV ExperiencedPRNT GMTWeek 120.5 Titer
HIV ExperiencedPRNT GMTWeek 442.3 Titer
HIV ExperiencedPRNT GMTWeek 688.9 Titer
HIV ExperiencedPRNT GMTWeek 876.1 Titer
Secondary

PRNT Seroconversion Rate

Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.

Time frame: within 32 weeks

Population: Per-protocol set

ArmMeasureGroupValue (NUMBER)
Healthy naïvePRNT Seroconversion RateWeek 878.9 percentage of subjects
Healthy naïvePRNT Seroconversion RateWeek 15.3 percentage of subjects
Healthy naïvePRNT Seroconversion RateWeek 678.9 percentage of subjects
Healthy naïvePRNT Seroconversion RateWeek 417.5 percentage of subjects
Healthy naïvePRNT Seroconversion RateWeek 3216.7 percentage of subjects
HIV naïvePRNT Seroconversion RateWeek 114.5 percentage of subjects
HIV naïvePRNT Seroconversion RateWeek 852.7 percentage of subjects
HIV naïvePRNT Seroconversion RateWeek 421.6 percentage of subjects
HIV naïvePRNT Seroconversion RateWeek 3212.5 percentage of subjects
HIV naïvePRNT Seroconversion RateWeek 658.1 percentage of subjects
Healthy ExperiencedPRNT Seroconversion RateWeek 880.0 percentage of subjects
Healthy ExperiencedPRNT Seroconversion RateWeek 160.0 percentage of subjects
Healthy ExperiencedPRNT Seroconversion RateWeek 680.0 percentage of subjects
Healthy ExperiencedPRNT Seroconversion RateWeek 3260.0 percentage of subjects
Healthy ExperiencedPRNT Seroconversion RateWeek 460.0 percentage of subjects
HIV ExperiencedPRNT Seroconversion RateWeek 462.6 percentage of subjects
HIV ExperiencedPRNT Seroconversion RateWeek 145.1 percentage of subjects
HIV ExperiencedPRNT Seroconversion RateWeek 3264.7 percentage of subjects
HIV ExperiencedPRNT Seroconversion RateWeek 878.0 percentage of subjects
HIV ExperiencedPRNT Seroconversion RateWeek 676.9 percentage of subjects
Secondary

Related Grade >=3 Adverse Events

Incidence of any Grade 3 or higher adverse drug reaction (missing, unknown, not evaluable, possibly, probably, or definitely related) to the study vaccine

Time frame: within 29 days after any vaccination

Population: Full Analysis set

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Healthy naïveRelated Grade >=3 Adverse Events7 Participants
HIV naïveRelated Grade >=3 Adverse Events26 Participants
Healthy ExperiencedRelated Grade >=3 Adverse Events0 Participants
HIV ExperiencedRelated Grade >=3 Adverse Events5 Participants
Secondary

Solicited General Adverse Events

Incidence of solicited general AEs (increased body temperature, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.

Time frame: within 8 days after any vaccination

Population: Full Analysis Set

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Healthy naïveSolicited General Adverse EventsHeadache: Related29 Participants
Healthy naïveSolicited General Adverse EventsFatigue: Any28 Participants
Healthy naïveSolicited General Adverse EventsChills: Grade >=30 Participants
Healthy naïveSolicited General Adverse EventsNausea: Any15 Participants
Healthy naïveSolicited General Adverse EventsHeadache: Any40 Participants
Healthy naïveSolicited General Adverse EventsNausea: Related12 Participants
Healthy naïveSolicited General Adverse EventsNausea: Grade >=33 Participants
Healthy naïveSolicited General Adverse EventsIncreased body temperature: Any9 Participants
Healthy naïveSolicited General Adverse EventsHeadache: Grade >=35 Participants
Healthy naïveSolicited General Adverse EventsMyalgia: Any30 Participants
Healthy naïveSolicited General Adverse EventsIncreased body temperature: Related5 Participants
Healthy naïveSolicited General Adverse EventsFatigue: Grade >=32 Participants
Healthy naïveSolicited General Adverse EventsMyalgia: Related28 Participants
Healthy naïveSolicited General Adverse EventsMyalgia: Grade >=34 Participants
Healthy naïveSolicited General Adverse EventsIncreased body temperature: Grade >=30 Participants
Healthy naïveSolicited General Adverse EventsFatigue: Related22 Participants
Healthy naïveSolicited General Adverse EventsChills: Any12 Participants
Healthy naïveSolicited General Adverse EventsChills: Related6 Participants
HIV naïveSolicited General Adverse EventsMyalgia: Grade >=311 Participants
HIV naïveSolicited General Adverse EventsMyalgia: Any122 Participants
HIV naïveSolicited General Adverse EventsIncreased body temperature: Grade >=32 Participants
HIV naïveSolicited General Adverse EventsChills: Grade >=33 Participants
HIV naïveSolicited General Adverse EventsFatigue: Any108 Participants
HIV naïveSolicited General Adverse EventsNausea: Any52 Participants
HIV naïveSolicited General Adverse EventsChills: Related42 Participants
HIV naïveSolicited General Adverse EventsNausea: Grade >=37 Participants
HIV naïveSolicited General Adverse EventsMyalgia: Related100 Participants
HIV naïveSolicited General Adverse EventsNausea: Related42 Participants
HIV naïveSolicited General Adverse EventsHeadache: Any117 Participants
HIV naïveSolicited General Adverse EventsIncreased body temperature: Any26 Participants
HIV naïveSolicited General Adverse EventsFatigue: Related84 Participants
HIV naïveSolicited General Adverse EventsIncreased body temperature: Related17 Participants
HIV naïveSolicited General Adverse EventsChills: Any58 Participants
HIV naïveSolicited General Adverse EventsHeadache: Grade >=311 Participants
HIV naïveSolicited General Adverse EventsHeadache: Related86 Participants
HIV naïveSolicited General Adverse EventsFatigue: Grade >=311 Participants
Healthy ExperiencedSolicited General Adverse EventsFatigue: Grade >=30 Participants
Healthy ExperiencedSolicited General Adverse EventsIncreased body temperature: Any1 Participants
Healthy ExperiencedSolicited General Adverse EventsIncreased body temperature: Related1 Participants
Healthy ExperiencedSolicited General Adverse EventsHeadache: Any1 Participants
Healthy ExperiencedSolicited General Adverse EventsHeadache: Grade >=30 Participants
Healthy ExperiencedSolicited General Adverse EventsMyalgia: Any1 Participants
Healthy ExperiencedSolicited General Adverse EventsMyalgia: Related1 Participants
Healthy ExperiencedSolicited General Adverse EventsMyalgia: Grade >=30 Participants
Healthy ExperiencedSolicited General Adverse EventsChills: Any0 Participants
Healthy ExperiencedSolicited General Adverse EventsChills: Related0 Participants
Healthy ExperiencedSolicited General Adverse EventsNausea: Any0 Participants
Healthy ExperiencedSolicited General Adverse EventsNausea: Related0 Participants
Healthy ExperiencedSolicited General Adverse EventsNausea: Grade >=30 Participants
Healthy ExperiencedSolicited General Adverse EventsFatigue: Any2 Participants
Healthy ExperiencedSolicited General Adverse EventsFatigue: Related1 Participants
Healthy ExperiencedSolicited General Adverse EventsIncreased body temperature: Grade >=30 Participants
Healthy ExperiencedSolicited General Adverse EventsHeadache: Related0 Participants
Healthy ExperiencedSolicited General Adverse EventsChills: Grade >=30 Participants
HIV ExperiencedSolicited General Adverse EventsIncreased body temperature: Any15 Participants
HIV ExperiencedSolicited General Adverse EventsFatigue: Any40 Participants
HIV ExperiencedSolicited General Adverse EventsMyalgia: Grade >=33 Participants
HIV ExperiencedSolicited General Adverse EventsMyalgia: Related26 Participants
HIV ExperiencedSolicited General Adverse EventsChills: Grade >=31 Participants
HIV ExperiencedSolicited General Adverse EventsFatigue: Related29 Participants
HIV ExperiencedSolicited General Adverse EventsMyalgia: Any35 Participants
HIV ExperiencedSolicited General Adverse EventsHeadache: Grade >=35 Participants
HIV ExperiencedSolicited General Adverse EventsFatigue: Grade >=33 Participants
HIV ExperiencedSolicited General Adverse EventsHeadache: Related17 Participants
HIV ExperiencedSolicited General Adverse EventsIncreased body temperature: Related11 Participants
HIV ExperiencedSolicited General Adverse EventsHeadache: Any29 Participants
HIV ExperiencedSolicited General Adverse EventsNausea: Related12 Participants
HIV ExperiencedSolicited General Adverse EventsNausea: Any22 Participants
HIV ExperiencedSolicited General Adverse EventsIncreased body temperature: Grade >=30 Participants
HIV ExperiencedSolicited General Adverse EventsNausea: Grade >=34 Participants
HIV ExperiencedSolicited General Adverse EventsChills: Related7 Participants
HIV ExperiencedSolicited General Adverse EventsChills: Any11 Participants
Secondary

Solicited Local Adverse Events

Incidence and intensity of solicited local AEs (pain, erythema, swelling). Percentages based on subjects with at least one completed diary card.

Time frame: within 8 days after any vaccination

Population: Full Analysis Set

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Healthy naïveSolicited Local Adverse EventsPain: Any79 Participants
Healthy naïveSolicited Local Adverse EventsPain: Grade >=39 Participants
Healthy naïveSolicited Local Adverse EventsErythema: Any68 Participants
Healthy naïveSolicited Local Adverse EventsSwelling: Any56 Participants
Healthy naïveSolicited Local Adverse EventsSwelling: Grade >=31 Participants
Healthy naïveSolicited Local Adverse EventsErythema: Grade >=32 Participants
HIV naïveSolicited Local Adverse EventsSwelling: Grade >=31 Participants
HIV naïveSolicited Local Adverse EventsSwelling: Any139 Participants
HIV naïveSolicited Local Adverse EventsPain: Any246 Participants
HIV naïveSolicited Local Adverse EventsErythema: Grade >=31 Participants
HIV naïveSolicited Local Adverse EventsPain: Grade >=328 Participants
HIV naïveSolicited Local Adverse EventsErythema: Any160 Participants
Healthy ExperiencedSolicited Local Adverse EventsPain: Grade >=31 Participants
Healthy ExperiencedSolicited Local Adverse EventsErythema: Grade >=30 Participants
Healthy ExperiencedSolicited Local Adverse EventsSwelling: Any6 Participants
Healthy ExperiencedSolicited Local Adverse EventsSwelling: Grade >=30 Participants
Healthy ExperiencedSolicited Local Adverse EventsPain: Any7 Participants
Healthy ExperiencedSolicited Local Adverse EventsErythema: Any7 Participants
HIV ExperiencedSolicited Local Adverse EventsErythema: Grade >=30 Participants
HIV ExperiencedSolicited Local Adverse EventsErythema: Any61 Participants
HIV ExperiencedSolicited Local Adverse EventsPain: Grade >=34 Participants
HIV ExperiencedSolicited Local Adverse EventsSwelling: Any52 Participants
HIV ExperiencedSolicited Local Adverse EventsPain: Any79 Participants
HIV ExperiencedSolicited Local Adverse EventsSwelling: Grade >=30 Participants
Secondary

Unsolicited Adverse Events: Incidence

Incidence of any unsolicited adverse events

Time frame: within 29 days after any vaccination

Population: Full Analysis Set

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Healthy naïveUnsolicited Adverse Events: Incidence59 Participants
HIV naïveUnsolicited Adverse Events: Incidence236 Participants
Healthy ExperiencedUnsolicited Adverse Events: Incidence3 Participants
HIV ExperiencedUnsolicited Adverse Events: Incidence73 Participants
Secondary

Unsolicited Adverse Events: Intensity

Occurrence of unsolicited adverse events by Intensity

Time frame: within 29 days after any vaccination

Population: Full Analysis Set

ArmMeasureGroupValue (NUMBER)
Healthy naïveUnsolicited Adverse Events: IntensityMissing0 events
Healthy naïveUnsolicited Adverse Events: IntensityTotal149 events
Healthy naïveUnsolicited Adverse Events: IntensityGrade 40 events
Healthy naïveUnsolicited Adverse Events: IntensityGrade 1113 events
Healthy naïveUnsolicited Adverse Events: IntensityGrade 34 events
Healthy naïveUnsolicited Adverse Events: IntensityGrade 232 events
HIV naïveUnsolicited Adverse Events: IntensityGrade 1410 events
HIV naïveUnsolicited Adverse Events: IntensityMissing0 events
HIV naïveUnsolicited Adverse Events: IntensityGrade 43 events
HIV naïveUnsolicited Adverse Events: IntensityTotal590 events
HIV naïveUnsolicited Adverse Events: IntensityGrade 2143 events
HIV naïveUnsolicited Adverse Events: IntensityGrade 334 events
Healthy ExperiencedUnsolicited Adverse Events: IntensityGrade 40 events
Healthy ExperiencedUnsolicited Adverse Events: IntensityGrade 13 events
Healthy ExperiencedUnsolicited Adverse Events: IntensityGrade 22 events
Healthy ExperiencedUnsolicited Adverse Events: IntensityMissing0 events
Healthy ExperiencedUnsolicited Adverse Events: IntensityGrade 31 events
Healthy ExperiencedUnsolicited Adverse Events: IntensityTotal6 events
HIV ExperiencedUnsolicited Adverse Events: IntensityGrade 228 events
HIV ExperiencedUnsolicited Adverse Events: IntensityTotal175 events
HIV ExperiencedUnsolicited Adverse Events: IntensityGrade 1134 events
HIV ExperiencedUnsolicited Adverse Events: IntensityMissing0 events
HIV ExperiencedUnsolicited Adverse Events: IntensityGrade 313 events
HIV ExperiencedUnsolicited Adverse Events: IntensityGrade 40 events
Secondary

Unsolicited Adverse Events: Relationship to Vaccination

Occurrence of unsolicited adverse events by relationship to study vaccine

Time frame: within 29 days after any vaccination

Population: Full Analysis Set

ArmMeasureGroupValue (NUMBER)
Healthy naïveUnsolicited Adverse Events: Relationship to VaccinationUnrelated/None45 events
Healthy naïveUnsolicited Adverse Events: Relationship to VaccinationTotal149 events
Healthy naïveUnsolicited Adverse Events: Relationship to VaccinationUnlikely40 events
Healthy naïveUnsolicited Adverse Events: Relationship to VaccinationPossible22 events
Healthy naïveUnsolicited Adverse Events: Relationship to VaccinationDefinite26 events
Healthy naïveUnsolicited Adverse Events: Relationship to VaccinationProbable16 events
Healthy naïveUnsolicited Adverse Events: Relationship to VaccinationMissing0 events
HIV naïveUnsolicited Adverse Events: Relationship to VaccinationPossible109 events
HIV naïveUnsolicited Adverse Events: Relationship to VaccinationDefinite31 events
HIV naïveUnsolicited Adverse Events: Relationship to VaccinationTotal590 events
HIV naïveUnsolicited Adverse Events: Relationship to VaccinationUnrelated/None236 events
HIV naïveUnsolicited Adverse Events: Relationship to VaccinationMissing2 events
HIV naïveUnsolicited Adverse Events: Relationship to VaccinationUnlikely167 events
HIV naïveUnsolicited Adverse Events: Relationship to VaccinationProbable45 events
Healthy ExperiencedUnsolicited Adverse Events: Relationship to VaccinationProbable1 events
Healthy ExperiencedUnsolicited Adverse Events: Relationship to VaccinationUnrelated/None0 events
Healthy ExperiencedUnsolicited Adverse Events: Relationship to VaccinationDefinite3 events
Healthy ExperiencedUnsolicited Adverse Events: Relationship to VaccinationMissing0 events
Healthy ExperiencedUnsolicited Adverse Events: Relationship to VaccinationTotal6 events
Healthy ExperiencedUnsolicited Adverse Events: Relationship to VaccinationUnlikely1 events
Healthy ExperiencedUnsolicited Adverse Events: Relationship to VaccinationPossible1 events
HIV ExperiencedUnsolicited Adverse Events: Relationship to VaccinationTotal175 events
HIV ExperiencedUnsolicited Adverse Events: Relationship to VaccinationMissing0 events
HIV ExperiencedUnsolicited Adverse Events: Relationship to VaccinationUnrelated/None87 events
HIV ExperiencedUnsolicited Adverse Events: Relationship to VaccinationPossible23 events
HIV ExperiencedUnsolicited Adverse Events: Relationship to VaccinationDefinite11 events
HIV ExperiencedUnsolicited Adverse Events: Relationship to VaccinationProbable12 events
HIV ExperiencedUnsolicited Adverse Events: Relationship to VaccinationUnlikely42 events
Secondary

Viral Load

Viral load (HIV-1 RNA levels) over time

Time frame: within 32 weeks

Population: Full Analysis Set (HIV infected subjects)

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Healthy naïveViral LoadWeek 321000 - <100004 Participants
Healthy naïveViral LoadWeek 1>=1000022 Participants
Healthy naïveViral LoadWeek 6Missing31 Participants
Healthy naïveViral LoadWeek 6<400240 Participants
Healthy naïveViral LoadWeek 6400 - <100018 Participants
Healthy naïveViral LoadWeek 0Missing13 Participants
Healthy naïveViral LoadWeek 0<400262 Participants
Healthy naïveViral LoadWeek 0400 - <100011 Participants
Healthy naïveViral LoadWeek 01000 - <1000042 Participants
Healthy naïveViral LoadWeek 0>=1000023 Participants
Healthy naïveViral LoadWeek 1Missing15 Participants
Healthy naïveViral LoadWeek 1<400257 Participants
Healthy naïveViral LoadWeek 1400 - <100013 Participants
Healthy naïveViral LoadWeek 11000 - <1000044 Participants
Healthy naïveViral LoadWeek 61000 - <1000041 Participants
Healthy naïveViral LoadWeek 6>=1000021 Participants
Healthy naïveViral LoadWeek 32Missing275 Participants
Healthy naïveViral LoadWeek 32>=100008 Participants
Healthy naïveViral LoadWeek 32<40059 Participants
Healthy naïveViral LoadWeek 32400 - <10005 Participants
HIV naïveViral LoadWeek 32Missing108 Participants
HIV naïveViral LoadWeek 1<400113 Participants
HIV naïveViral LoadWeek 1>=100004 Participants
HIV naïveViral LoadWeek 321000 - <100001 Participants
HIV naïveViral LoadWeek 6Missing10 Participants
HIV naïveViral LoadWeek 1400 - <10002 Participants
HIV naïveViral LoadWeek 6<400105 Participants
HIV naïveViral LoadWeek 11000 - <100005 Participants
HIV naïveViral LoadWeek 6400 - <10003 Participants
HIV naïveViral LoadWeek 0Missing5 Participants
HIV naïveViral LoadWeek 32>=100000 Participants
HIV naïveViral LoadWeek 0<400112 Participants
HIV naïveViral LoadWeek 61000 - <100006 Participants
HIV naïveViral LoadWeek 0400 - <10003 Participants
HIV naïveViral LoadWeek 32400 - <10000 Participants
HIV naïveViral LoadWeek 01000 - <100006 Participants
HIV naïveViral LoadWeek 6>=100007 Participants
HIV naïveViral LoadWeek 0>=100005 Participants
HIV naïveViral LoadWeek 32<40022 Participants
HIV naïveViral LoadWeek 1Missing7 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026