Phase 2
Completed N=198
Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults
Healthy
Source: ClinicalTrials.gov NCT02788045 ↗
Enrolled (actual)
198
Serious AEs
4.6%
Results posted
Jun 2023
Primary outcomePrimary: Percentage of Participants With Solicited Local Adverse Events (AEs) Post First Vaccination — 70.9; 78.2; 27.3 percentage of participants
Summary
The purpose of this study is to assess the safety/tolerability of the 2 different vaccine regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the different vaccine schedules will be assessed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Local Adverse Events (AEs) Post First Vaccination |
70.9; 78.2; 27.3 | — |
| PRIMARY Percentage of Participants With Solicited Local AEs Post Second Vaccination |
83.3; 76.5; 50 | — |
| PRIMARY Percentage of Participants With Solicited Local AEs Post Third Vaccination |
80.8; 79.6; 21.9 | — |
| PRIMARY Percentage of Participants With Solicited Local AEs Post Fourth Vaccination |
84; 68.9; 29.6 | — |
| PRIMARY Percentage of Participants With Solicited Systemic AEs Post First Vaccination |
69.1; 83.6; 54.5 | — |
| PRIMARY Percentage of Participants With Solicited Systemic AEs Post Second Vaccination |
66.7; 54.9; 40.6 | — |
| PRIMARY Percentage of Participants With Solicited Systemic AEs Post Third Vaccination |
59.6; 44.9; 34.4 | — |
| PRIMARY Percentage of Participants With Solicited Systemic AEs Post Fourth Vaccination |
58.5; 53.3; 33.3 | — |
| PRIMARY Percentage of Participants With Unsolicited AEs for 28 Days After First Vaccination |
38.2; 41.8; 30.3 | — |
| PRIMARY Percentage of Participants With Unsolicited AEs for 28 Days After Second Vaccination |
30.4; 23.5; 37.5 | — |
| PRIMARY Percentage of Participants With Unsolicited AEs for 28 Days After Third Vaccination |
28.3; 20.4; 21.9 | — |
| PRIMARY Percentage of Participants With Unsolicited AEs for 28 Days After Fourth Vaccination |
36.2; 22.2; 40.7 | — |
| PRIMARY Percentage of Participants With Discontinuations From Vaccination Due to AEs |
0; 1.8; 6.1 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) During Main Study |
5.5; 0; 0 | — |
| PRIMARY Percentage of Participants With SAEs During Long Term Extension (LTE) Period |
5.2 | — |
| PRIMARY Percentage of Participants With AEs of Special Interest During Main Study |
0; 0; 0 | — |
| PRIMARY Percentage of Participants With AEs of Special Interest During LTE Period |
— | — |
| PRIMARY Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 28 |
100; 100; 19.4; 100; 100; 12.9 | — |
| PRIMARY Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 52 |
100; 100; 0; 100; 100; 22.2 | — |
| PRIMARY Percentage of Responders for Envelop (Env) Clade A (92UG037.1), B (1990a), and C (Con C), (C97ZA.012) Specific Binding Antibody Titers at Week 72 |
100; 100; 2; 100; 100; 11.1 | — |
| SECONDARY Percentage of Responders for Human Immunodeficiency Virus Neutralizing Antibody (HIV nAb) |
99; 66.7; 0; 100; 90; 0 | — |
| SECONDARY Percentage of Responders for Env Antibody-dependent Cellular Phagocytosis (ADCP) gp Antibody |
72.4; 36.2; 0; 69.4; 57.4; 0 | — |
| SECONDARY Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Assessed Using Enzyme-linked Immunospot Assay (ELISpot) |
96; 79.2; 3.2; 95.7; 85; 3.8 | — |
| SECONDARY Percentage of Responders for Immunoglobulin G1 (IgG1) and IgG3 Gylcoprotein (gp) 140 Binding Antibody Assessed Using Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) |
72.8; 61.4; 0; 73.1; 67.5; 0 | — |
| SECONDARY Percentage of Responders for CD4+ and CD8+ T-Cell Responses |
53.61; 41.67; 3.23; 64.84; 50.00; 53.85 | — |
| SECONDARY Percentage of Participants With T-cell Development |
— | — |
Eligibility Criteria
Inclusion Criteria
- Are negative for human immunodeficiency virus (HIV) infection at screening
- Is healthy on the basis of physical examination, medical history, electrocardiogram (ECG), and vital signs measurement performed at screening
- Are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
- Female participants of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [beta hCG]) at the Screening visit, and a negative urine pregnancy test pre-dose on Day 1
- Are assessed by the clinic staff as being at low risk for HIV infection
Exclusion Criteria
- Has chronic hepatitis B (measured by hepatitis B surface antigen test) or active hepatitis C (measured by hepatitis C virus [HCV] Ab test; if positive, HCV ribonucleic acid [RNA] PCR test will be used to confirm active versus past HCV infection), active syphilis infection, chlamydia, gonorrhea, or trichomonas . Active syphilis documented by serology unless positive serology is due to past treated infection
- Has had a thyroidectomy or active thyroid disease requiring medication during the last 12 months (not excluded: a stable thyroid supplementation)
- Has had major psychiatric illness and/or substance abuse problems during the past 12 months (including hospitalization or periods of work disability) that in the opinion of the investigator would preclude participation
- Has been in receipt of any licensed vaccine within 14 days prior to the first dose of study vaccine/placebo, plans to receive within 14 days after the first study vaccination, or plans to receive within 14 days before or after the second, third or fourth vaccination
- Is a recipient of a prophylactic or therapeutic HIV vaccine candidate at any time, or a recipient of other experimental vaccine(s) within the last 12 months prior to the Day 1 visit (Vaccination 1). For participants who received an experimental vaccine (except HIV vaccine) more than 12 months prior to the Day 1 visit (Vaccination 1), documentation of the identity of the experimental vaccine must be provided to the sponsor, who will determine eligibility on a case-by-case basis
Data sourced from ClinicalTrials.gov (NCT02788045). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.