Vaccine Regimen for HIV Prevention

Recruiting at 5 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Glucocorticoids, Blood products, Immunoglobulin, others

Disqualifiers: Pregnancy, Diabetes, Immunodeficiency, Seizures, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

42 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain medications that impair immune response, like glucocorticoids, or recent receipt of vaccines or investigational agents, may affect eligibility. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment 426c.Mod.Core-C4b, HxB2.WT.Core-C4b for HIV prevention?

The research highlights the importance of developing an effective HIV vaccine, with some studies showing promising results using different vaccine regimens. Although specific data on 426c.Mod.Core-C4b, HxB2.WT.Core-C4b is not provided, the general progress in HIV vaccine development, including the use of adjuvants to improve immune response, supports the potential effectiveness of new vaccine strategies. ^{1 2 3 4 5}

Is the HIV vaccine regimen safe for humans?

The HIV vaccine regimen has been tested in several studies and is generally safe for humans. Most side effects were mild, like pain at the injection site, and there were no serious vaccine-related issues reported in the trials. ^{6 7 8 9 10}

How is the 426c.Mod.Core-C4b treatment for HIV prevention different from other treatments?

The 426c.Mod.Core-C4b treatment is unique because it is part of a vaccine regimen aimed at preventing HIV, which is different from existing treatments that typically focus on managing the infection after it occurs. This approach is novel as it seeks to provide immunity and prevent the virus from taking hold in the first place, unlike traditional antiretroviral therapies that are used to control the virus in people who are already infected. ^{1 5 11 12 13}

What is the purpose of this trial?

This is a partially randomized, open-label phase 1 study to evaluate the safety and immunogenicity of a priming regimen of 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum followed by boosts with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum. The primary hypothesis is that the boosting with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum will further mature broadly neutralizing antibody (bnAb)-precursor B-cell lineages elicited by 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum. 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum has been tested in HVTN 301 previously, whereas the HxB2.WT.Core-C4b will be first-in-human (FIH).

Eligibility Criteria

This trial is for adults without HIV who are in good health. Specific eligibility details aren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or their safety.

Inclusion Criteria

Agrees not to enroll in another study of an investigational agent during participation in the trial. Approvals required if already enrolled in another clinical trial

My hemoglobin levels match the required levels for my gender and hormone therapy status.

White blood cell (WBC) count within specified range

Exclusion Criteria

Previous receipt of certain investigational agents

History of certain reactions or conditions

I don't have any health issues that could make treatment unsafe for me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Priming

Participants receive a priming regimen of 426c.Mod.Core-C4b adjuvanted with 3M-052 AF + Alum

12 weeks

Multiple visits for priming doses

Boosting

Participants receive boosts with HxB2.WT.Core-C4b adjuvanted with 3M-052 AF + Alum

12 weeks

Visits at 2 weeks after each boost

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Visits at week 29, week 39, week 41, and week 51

Treatment Details

Interventions

• 426c.Mod.Core-C4b
• HxB2.WT.Core-C4b

Trial Overview The study tests a new vaccine strategy against HIV/AIDS. It starts with a 'prime' shot of 426c.Mod.Core-C4b with adjuvants (substances to boost immune response) followed by 'boost' shots of HxB2.WT.Core-C4b, also with adjuvants. The goal is to see if this can improve immune defense by maturing specific antibody-producing cells.

Participant Groups

Group I: Group 1 Active Control 5 Interventions

One fractional dose of 426c.Mod.Core-C4b and two bolus doses of HxB2.WT.Core-C4b

Group II: Group 2A Active Control 5 Interventions

One fractional dose and one bolus dose of 426c.Mod.Core-C4b two bolus doses of HxB2.WT.Core-C4b

Group III: Group 2B Active Control 5 Interventions

One split dose and one bolus of 426c.Mod.Core-C4b and two bolus doses of HxB2.WT.Core-C4b

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Immune responses to HIV vaccines and potential impact on control of acute HIV-1 infection. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Induction of strong HIV-1-specific CD4+ T-cell responses using an HIV-1 gp120/NefTat vaccine adjuvanted with AS02A in antiretroviral-treated HIV-1-infected individuals. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Status of vaccine research and development of vaccines for HIV-1. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Prophylactic HIV vaccine: vaccine regimens in clinical trials and potential challenges. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Modeling HIV vaccine trials of the future. [2019]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Cellular and humoral responses to an HIV DNA prime by electroporation boosted with recombinant vesicular stomatitis virus expressing HIV subtype C Env in a randomized controlled clinical trial. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of an HIV-1 gp120-CD4 chimeric subunit vaccine in a phase 1a randomized controlled trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity of a novel Clade B HIV-1 vaccine combination: Results of phase 1 randomized placebo controlled trial of an HIV-1 GM-CSF-expressing DNA prime with a modified vaccinia Ankara vaccine boost in healthy HIV-1 uninfected adults. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

The F4/AS01B HIV-1 Vaccine Candidate Is Safe and Immunogenic, But Does Not Show Viral Efficacy in Antiretroviral Therapy-Naive, HIV-1-Infected Adults: A Randomized Controlled Trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Enhancement of human immunodeficiency virus type 1-DNA vaccine potency through incorporation of T-helper 1 molecular adjuvants. [2017]

11. Netherlands pubmed.ncbi.nlm.nih.gov

The cost-effectiveness of a modestly effective HIV vaccine in the United States. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Immune-correlates analysis of an HIV-1 vaccine efficacy trial. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Safety and reactogenicity of canarypox ALVAC-HIV (vCP1521) and HIV-1 gp120 AIDSVAX B/E vaccination in an efficacy trial in Thailand. [2021]