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Phase 2 Completed N=155 Randomized Double-blind Prevention

A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults

Healthy
Source: ClinicalTrials.gov NCT02935686 ↗
Enrolled (actual)
155
Serious AEs
3.4%
Results posted
Jan 2025
Primary outcomePrimary: Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 1 — 21; 78; 6; 20 Participants

Summary

The primary purpose of this study is to assess safety/tolerability of the different vaccine regimens and of a late boost vaccination; and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different vaccine regimens.

Outcome Measures

OutcomeResultp-value
PRIMARY
Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 1
21; 78; 6; 20; 80; 16
PRIMARY
Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 2
19; 66; 5; 15; 58; 13
PRIMARY
Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 3
18; 73; 12; 10; 55; 8
PRIMARY
Main Study: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post-vaccination 4
13; 70; 7; 11; 53; 6
PRIMARY
Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 1
8; 40; 12
PRIMARY
Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 2
6; 35; 7
PRIMARY
Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 3
5; 38; 8
PRIMARY
Main Study: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post-vaccination 4
3; 30; 5
PRIMARY
Main Study: Number of Participants Who Discontinued Study Vaccination Due to AEs
1; 0; 0
PRIMARY
Main Study: Number of Participants With Serious Adverse Events (SAEs)
0; 0; 0
PRIMARY
Main Study and LTE Study: Number of Participants With Adverse Events of Special Interest (AESIs)
0; 0; 0
PRIMARY
Late-boost (LB) Vaccination Phase: Number of Participants Who Discontinued Study Due to AEs
0; 1
PRIMARY
Late-boost (LB) Vaccination Phase: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 7 Days Post Late Boost Vaccination
37; 9
PRIMARY
Late-boost (LB) Vaccination Phase: Number of Participants With Unsolicited Adverse Events (AEs) for 28 Days Post Late Boost Vaccination
11; 4
PRIMARY
Late-boost (LB) Vaccination Phase: Number of Participants With Serious Adverse Events (SAEs)
1; 1
PRIMARY
Late-boost (LB) Vaccination Phase: Number of Participants With AESIs of HIV Infection Up to End of Study
0; 2
PRIMARY
Late-boost (LB) Vaccination Phase: Number of Participants With AESIs of Thrombosis With Thrombocytopenia Syndrome (TTS)
0; 0
PRIMARY
Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 28
99731.9; 88412.7; 312.5; 67190.3; 71067.3; 94.4
PRIMARY
Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1), B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 52
104042.2; 139725.1; 312.5; 77042.3; 133424.3; 94.3
PRIMARY
Main Study: Geometric Mean of Envelope (Env) Clade A (92UG037.1) B (1990a), C (Con C), (C97ZA.012), Mos 1 Specific Binding Antibodies (Abs) Responses As Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 72
33049.4; 39174.4; 312.5; 20625; 33177.5; 99.1
PRIMARY
Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 28
100; 100.0; 0; 100; 100; 0
PRIMARY
Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 52
100; 100.0; 0; 100; 100; 0
PRIMARY
Main Study: Percentage of Responders for Envelope (Env)-Specific Binding Antibody Titers at Week 72
93.8; 94.7; 0; 100; 96.1; 0
PRIMARY
Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 192
4044.7; 3398.9; 6816.4; 5125.0
PRIMARY
Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 193
28412.2; 3652.9; 46851.6; 4505.3
PRIMARY
Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 196
169017.3; 3438.1; 174004.6; 5153.9
PRIMARY
Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 204
65259.8; 3440.8; 74715.2; 5303.2
PRIMARY
Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 216
27307.4; 3237.3; 43831.8; 5029.6
PRIMARY
Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 240
18223.4; 3031.1; 25693.2; 4491.1
PRIMARY
Late-boost (LB) Vaccination Phase: Geometric Mean of Envelope (Env) Mos 1 Specific Binding Antibodies (Abs) Response as Assessed Using Enzyme-linked Immunosorbent Assay (ELISA) at Week 288
18799.1; 4742.3; 15757.0; 3933.1
SECONDARY
Main Study: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses
100.0; 100.0; 0; 100.0; 100.0; 0
SECONDARY
Long-term Extension (LTE) Phase: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses
SECONDARY
Late-boost (LB) Vaccination Phase: Percentage of Responders of Env-Specific Neutralizing Antibody (nAbs) for Tier 1 Viruses
SECONDARY
Main Study: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140)
90.0; 94.4; 32.0; 90.0; 98.9; 0
SECONDARY
Long-term Extension (LTE) Phase: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140)
SECONDARY
Late-boost (LB) Vaccination Phase: Percentage of Responders for Env-Specific Functional Antibody Response (Env ADCP gp140)
SECONDARY
Main Study: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3)
65.0; 76.7; 0; 76.5; 75.6; 0
SECONDARY
Long-term Extension (LTE) Phase: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3)
SECONDARY
Late-boost (LB) Vaccination Phase: Percentage of Responders for Env-Specific Binding Ab Isotypes (Immunoglobulin [Ig] G1 and IgG3)
SECONDARY
Main Study: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol)
90.5; 82.0; 0; 82.4; 87.8; 4.3
SECONDARY
Long-term Extension (LTE) Phase: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol)
SECONDARY
Late-boost (LB) Vaccination Phase: Percentage of Interferon (IFN)-Gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) Peptide Pools of Env/Group-Specific Antigen (Gag)/ Polymerase (Pol)
SECONDARY
Main Study: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality
50.00; 80.95; 0; 64.29; 77.46; 0
SECONDARY
Long-term Extension (LTE) Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality
SECONDARY
Late-boost (LB) Vaccination Phase: Percentage of Responders With Cluster of Differentiation (CD)4+ and CD8+ T-Cell Functionality
82.6; 57.1; 91.3; 83.3; 82.6; 57.1
SECONDARY
Main Study: Percentage of Participants With T-Cell Development
SECONDARY
Long-term Extension (LTE) Phase: Percentage of Participants With T-Cell Development
SECONDARY
Late-boost (LB) Vaccination Phase: Percentage of Participants With T-Cell Development

Eligibility Criteria

Inclusion Criteria

  • Participant must be healthy on the basis of medical history, physical examination, and vital signs measurement performed at screening
  • Participants are negative for human immunodeficiency virus (HIV) infection at screening
  • Participants are amenable to HIV-risk reduction counseling and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
  • All female participants of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) at the screening visit, and a negative urine pregnancy test pre-dose on Day 1
  • Participants are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
  • Participant must be enrolled in the LTE phase to receive the late boost vaccination

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] polymerase chain reaction (PCR) test will be used to confirm active versus past HCV infection), active syphilis infection, chlamydia, gonorrhea, or trichomonas
  • In the 12 months prior to randomization, participant has a history of newly acquired herpes simplex virus type 2 (HSV-2), syphilis, gonorrhea, non-gonococcal urethritis, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B
  • Participant has had major surgery (eg, requiring general anesthesia) within the 4 weeks before screening, or will not have fully recovered from surgery, or has surgery planned through the course of the study
  • Participant has had a thyroidectomy or active thyroid disease requiring medication during the last 12 months (not excluded: a stable thyroid supplementation)
  • Current or past drug/alcohol use that investigator assesses poses any more than a remotely increased risk of the ability of the participant to comply with the protocol requirements
  • Has been in receipt of any licensed vaccine within 14 days prior to the first dose of study vaccine or 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02935686). 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.

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