Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523… (NCT04983030) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Safety, Immunogenicity, Efficacy of Ad26.Mos4.HIV, MVA-BN-HIV and PGT121, PGDM1400, and VRC07-523LS in HIV-1-Infected Adults
United States36 participantsStarted 2022-04-01
Plain-language summary
A multicenter, randomized, parallel-group, placebo-controlled, double-blind, Phase 1/2a clinical study to investigate the safety, tolerability, immunogenicity and exploratory efficacy of a vaccine regimen consisting of an Ad26.Mos4.HIV prime and a boost with Modified Vaccinia Ankara (MVA)-BN-HIV in combination with broadly neutralizing antibodies (bNAb) PGT121, PGDM1400, and VRC07-523LS in human immunodeficiency virus type 1 (HIV-1)-infected study participants on suppressive anti-retroviral therapy (ART).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Each potential study participant must pass the Test of Understanding (TOU), indicating that he or she understands the purpose of, and procedures required for the study, after reading the informed consent and after the investigator or designee has provided detailed information on the study and has answered the potential study participant's questions. Each study participant must subsequently sign the ICF, indicating that he or she is willing to participate in the study.
✓. Each study participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
✓. Study participants are ≥18 to ≤70 years old on the day of signing the ICF.
✓. Each study participant must have documented HIV-1 infection.
✓. Must be on suppressive ART for at least 48 weeks prior to screening. ART is defined as a combination therapy regimen including at least 2 compounds, e.g., integrase inhibitor and nucleoside reverse transcriptase inhibitors (such as DovatoTM) or more than 2 compounds, e.g., 2x nucleoside reverse transcriptase inhibitors plus integrase inhibitor.
✓. Must have a plasma HIV RNA \<50 cps/mL at screening and at least 1 documented evidence of plasma HIV RNA \<50 cps/mL after the last ART change.
✓. Must be willing to undergo ATI.
What they're measuring
1
Percentage of Participants With Solicited Local Adverse Events (AEs) as a Measure of Safety and Tolerability
Timeframe: 7 days post-investigational product administration
2
Percentage of Participants With Solicited Systemic AEs as a Measure of Safety and Tolerability
Timeframe: 7 days post-investigational product administration
3
Percentage of Participants With Unsolicited AEs as a Measure of Safety and Tolerability
Timeframe: Approximately up to 72 weeks
4
Percentage of Participants With Adverse Events of Special Interest (AESIs)
Timeframe: From first vaccination until 6 months after last vaccination.
5
Frequency of Epitope Recognition by Enzyme-Linked Immunospot (ELISPOT)
Timeframe: Up to post-vaccination follow-up period until Week 72
6
Total IgG and Subclass Specific Antibody Titer
Timeframe: Up to post-vaccination follow-up period until Week 72 ]
7
Antiviral activity - Percentage of participants who maintain plasma HIV RNA <1000 copies/mL
. Must be medically stable as confirmed by medical history, physical examination, vital signs, and clinical laboratory tests performed at screening, and as per the investigator's discretion.
Exclusion criteria
✕1. For participants who are able to become pregnant, negative serum or urine pregnancy test (with a sensitivity of 15-25 mIU/mL) within 24 hours prior to Stage 1 randomization
✕2. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction starting from the first vaccination at Week 0 visit and for a period of 24 weeks after last dose of bNAb.
✕. Anyone who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study.
✕. Anyone with contraindication to intramuscular injections, placement of intravenous lines, and blood draws eg, bleeding disorders. NOTE: nonsteroidal anti- inflammatory drugs (NSAIDS) and acetylsalicylic acid containing preparations have to be stopped for 5 days before and after planned leukapheresis.
✕. Anyone with acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0oC within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted.
✕. Any history of an HIV-associated malignancy (including Kaposi's sarcoma), and any type of lymphoma, or virus-associated cancers.
✕. Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the 36 months prior to Stage 1 randomization or for whom such therapies are expected in the next 12 months (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence).
✕. Anyone with a history of an underlying clinically significant acute or uncontrolled chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the study participant.