Trial · NCT02968849

Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa

NCT02968849, Phase 2, Phase 3, Completed, National Institute of Allergy and Infectious Diseases (NIAID); results first posted 2023-02-08

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa. Trials, record NCT02968849. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02968849

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa
NCT number: NCT02968849
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 5,404 participants, actual
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions: HIV Infections
Interventions: ALVAC-HIV (vCP2438), Bivalent Subtype C gp120/MF59, Placebo
First posted: 2016-11-21
Last updated: 2026-05-04
Results first posted: 2023-02-08

Source ClinicalTrials.gov

Registered outcomes30

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment	Measured through 24 months after first vaccination	Vaccine efficacy was calculated as 1 minus the hazard ratio for HIV-1 infection, which was estimated using a sex-stratified Cox proportional-hazards (Cox PH) model and tested using a sex-stratified log-rank test. Vaccine efficacy was also measured using a ratio of cumulative incidences (CIR) of HIV-1 infection in the vaccine group as compared with the placebo group, which was calculated using Nelson-Aalen cumulative hazard estimates and tested using a Wald test.
Primary	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Measured through 3 full days following each vaccination	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Primary	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Measured through 3 full days following each vaccination	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Primary	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Measured through 3 full days following each vaccination	Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Primary	Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product	Measured through 30 days after each vaccination	For participants reporting multiple AEs over the time frame, the maximum relationship is counted.
Primary	Number of Participants Reporting Adverse Events (AEs), by Severity Grade	Measured through 30 days after each vaccination	For participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
Primary	Number of Participants Reporting Serious Adverse Events (SAEs)	Measured through 12 months after last vaccination	Measured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).
Primary	Number of Participants Reporting Adverse Events of Special Interest (AESIs)	Measured through 12 months after last vaccination	Adverse events of special interest (AESI) were described in Appendix J of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases.
Primary	Number of Participants Reporting New Chronic Medical Conditions	Measured through 12 months after last vaccination	A new chronic medical condition is defined as a new onset or exacerbation of medical condition requiring 2 or more visits to a medical provider during a period of at least 30 days.
Primary	Number of Participants With Early Study Termination Associated With an AE or Reactogenicity	Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)	From the termination form, early study termination associated with an AE or reactogenicity reasons are tabulated by treatment group.

1 to 10 of 30Source ClinicalTrials.gov

See all 30 registered outcomes

Outcomes30

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment	Measured through 24 months after first vaccination	MITT cohort	events per 100 person-years	NUMBER
PRIMARY	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Measured through 3 full days following each vaccination	Safety cohort	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration	Measured through 3 full days following each vaccination	Safety cohort	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms	Measured through 3 full days following each vaccination	Safety cohort	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product	Measured through 30 days after each vaccination	Safety cohort	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Reporting Adverse Events (AEs), by Severity Grade	Measured through 30 days after each vaccination	Safety cohort	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Reporting Serious Adverse Events (SAEs)	Measured through 12 months after last vaccination	Safety cohort	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Reporting Adverse Events of Special Interest (AESIs)	Measured through 12 months after last vaccination	Safety cohort	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants Reporting New Chronic Medical Conditions	Measured through 12 months after last vaccination	Safety cohort	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Number of Participants With Early Study Termination Associated With an AE or Reactogenicity	Measured through study completion (through 6 months after confirmation of HIV-1 diagnosis for participants who acquired HIV and through 12 months after last vaccination for the rest)	Safety cohort	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 30Source ClinicalTrials.gov

See all 30 outcomes

Results by group543

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment	Vaccine	Cox PH method	0.034	events per 100 person-years
Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment	Placebo	Cox PH method	0.033	events per 100 person-years
Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment	Vaccine	CIR method	0.034	events per 100 person-years
Incidence Rate of HIV-1 Infection Diagnosed After Enrollment (Concurrent With First Vaccination) Through 24 Months After Enrollment	Placebo	CIR method	0.033	events per 100 person-years
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Vaccine	Pain / None	2161	Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Placebo	Pain / None	2539	Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Vaccine	Pain / Mild	480	Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Placebo	Pain / Mild	149	Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Vaccine	Pain / Moderate	62	Participants
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness	Placebo	Pain / Moderate	12	Participants

1 to 10 of 543Source ClinicalTrials.gov

See all 543 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Vaccine	2,704
Overall Study	STARTED	Placebo	2,700
Overall Study	Modified Intent-to-Treat (MITT) Cohort	Vaccine	2,695
Overall Study	Modified Intent-to-Treat (MITT) Cohort	Placebo	2,689
Overall Study	MITT Infected Cohort	Vaccine	151
Overall Study	MITT Infected Cohort	Placebo	143
Overall Study	Week 26 At-Risk Cohort	Vaccine	2,430
Overall Study	Week 26 At-Risk Cohort	Placebo	2,393
Overall Study	Immunogenicity Cohort	Vaccine	120
Overall Study	Immunogenicity Cohort	Placebo	10

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events1,274

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Any Event in SOC	Blood and lymphatic system disorders	Vaccine	11	2,704	12
other	Any Event in SOC	Blood and lymphatic system disorders	Placebo	11	2,700	12
other	Anaemia	Blood and lymphatic system disorders	Vaccine	1	2,704	1
other	Anaemia	Blood and lymphatic system disorders	Placebo	1	2,700	1
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Vaccine	9	2,704	9
other	Iron deficiency anaemia	Blood and lymphatic system disorders	Placebo	5	2,700	5
other	Lymphadenitis	Blood and lymphatic system disorders	Vaccine	0	2,704	0
other	Lymphadenitis	Blood and lymphatic system disorders	Placebo	1	2,700	1
other	Lymphadenopathy	Blood and lymphatic system disorders	Vaccine	1	2,704	1
other	Lymphadenopathy	Blood and lymphatic system disorders	Placebo	5	2,700	5

1 to 10 of 1,274Source ClinicalTrials.gov

See all 1,274 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Vaccine	8	2,704
Total, all-cause mortality	Placebo	10	2,700
Total, other adverse events	Vaccine	1,707	2,704
Total, other adverse events	Placebo	1,704	2,700
Total, serious adverse events	Vaccine	103	2,704
Total, serious adverse events	Placebo	95	2,700

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33761206	BACKGROUND	PubMed
34895272	DERIVED	PubMed
35758878	BACKGROUND	PubMed
37355583	DERIVED	PubMed
38772835	DERIVED	PubMed
40190112	DERIVED	PubMed
41121745	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Vaccine vs Placebo: deaths from any cause	Trial comparisons
Vaccine vs Placebo: Number of Participants With Viral Sequences at HIV-1 Diagnosis	Trial comparisons
Vaccine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02968849

GET https://conductscience.org/api/trials/v1/NCT02968849/registered?page=2

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