HIV Vaccines for HIV/AIDS

No longer recruiting at 5 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

Must be taking: PrEP

Must not be taking: Glucocorticoids, Immunotherapy

Disqualifiers: Pregnancy, Diabetes, Immunodeficiency, 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: 13

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new vaccines for HIV, the virus that leads to AIDS. Researchers aim to determine if these vaccines, combined with adjuvants (which boost the body's immune response), are safe and can trigger an immune reaction. Participants are divided into groups to receive different combinations and doses of these vaccines, including CD4BS CH505M5 Pr-NP1 and CH505TF chTrimer. The trial seeks volunteers in good general health, at low risk of acquiring HIV, and who have tested negative for HIV. Individuals who maintain a lifestyle that keeps them at low risk for HIV and have had no serious reactions to vaccines may find this trial suitable. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive these new vaccines.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that might impair your immune response, like certain steroids, you may need to discuss this with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the CD4BS CH505M5 Pr-NP1 vaccine is being tested for safety in healthy individuals without HIV. Early results from other studies suggest that the vaccine helps the body produce antibodies to combat HIV. However, more information is needed to understand how well individuals tolerate this vaccine.

The CH505TF chTrimer vaccine is under study for safety in people living with HIV. These studies aim to determine if the vaccine is safe and well-tolerated. While results are still being collected, the research is promising regarding its safety.

Both vaccines are in the early stages of clinical trials, meaning they are still being tested for safety in humans. This phase is crucial for identifying any potential side effects and understanding how participants respond to the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these HIV vaccine treatments because they represent a novel approach to preventing HIV/AIDS. Unlike existing antiretroviral therapies that manage the virus, these vaccines aim to prevent HIV infection by using the CD4BS CH505M5 Pr-NP1 component, which is designed to elicit a strong immune response against the virus. Some treatment groups also include innovative adjuvants like ACU-026-001-1 and 3M-052-AF, which boost the body's immune response, potentially making these vaccines more effective than traditional options. Additionally, combining these vaccine components with the CH505TF chTrimer offers a new strategy to enhance immune protection. This innovative approach could pave the way for long-lasting protection against HIV, a significant advancement over current preventive measures.

What evidence suggests that this trial's treatments could be effective for HIV/AIDS?

Research has shown that the CD4BS CH505M5 Pr-NP1 vaccine, which participants in this trial may receive, can trigger the body's immune response. In earlier human trials, this vaccine successfully initiated the creation of special antibodies that fight HIV. Similarly, the CH505TF chTrimer vaccine, another treatment option in this trial, produced strong antibodies against HIV. Early studies found that combining this vaccine with an immune-boosting ingredient led to a strong response in participants. These findings suggest that both vaccines could help the body fight HIV effectively. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults without HIV who are in good health. Participants will be part of a study testing two experimental HIV vaccines combined with different adjuvants to boost immune response. The trial excludes individuals under certain medications, those with immune system issues, or anyone with conditions that might interfere with the study.

Inclusion Criteria

ALT levels below specified threshold

Platelet count within specified range

In good general health according to the clinical judgment of the site investigator

Exclusion Criteria

Breastfeeding or pregnant

Receipt of non-HIV experimental vaccine(s) within the last 1 year

My asthma meets specific health criteria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive 60 mcg of CD4BS CH505M5 Pr-NP1 administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4

4 months

3 visits (in-person)

Treatment Part B

Participants receive 60 mcg of CD4BS CH505M5 Pr-NP1 with adjuvant, followed by 300 mcg of CH505TF chTrimer with adjuvant at months 6 and 8

8 months

5 visits (in-person)

Treatment Part C

Participants receive 100 mcg of CD4BS CH505M5 Pr-NP1 with adjuvant, followed by 300 mcg of CH505TF chTrimer with adjuvant at months 6 and 8

8 months

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CD4BS CH505M5 Pr-NP1
• CH505TF chTrimer

Trial Overview The clinical trial is evaluating the safety and effectiveness of two HIV vaccine candidates: CD4BS CH505M5 Pr-NP1 and CH505 TF chTrimer. These are given alongside adjuvants—either Lipid Nanoparticles (LNPs) or 3M-052-AF plus Alum—to enhance immunity.

How Is the Trial Designed?

Group I: Part C - Group 7 Experimental Treatment 4 Interventions

* 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4 * Followed by 300 mcg of CH505TF chTrimer, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8.

Group II: Part C - Group 6 Experimental Treatment 4 Interventions

* 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 3 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4, * Followed by 300 mcg of CH505TF chTrimer, admixed with 3 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8.

Group III: Part C - Group 5 Experimental Treatment 3 Interventions

Low dose: * 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 1.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4, * Followed by 300 mcg of CH505TF chTrimer, admixed with 1mg empty LNP adjuvant to be administered at months 6 and 8. OR, High Dose: * 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 2.0 mg of ACU-026-001-01 adjuvant to be administered as two 0.5 mL doses intramuscularly at month 0, 2, and 4, * Followed by 300 mcg of CH505TF chTrimer, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered at months 6 and 8.

Group IV: Part B - Group 4 Experimental Treatment 4 Interventions

* 60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4 * Followed by 300 mcg of CH505TF chTrimer, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8.

Group V: Part B - Group 3 Experimental Treatment 3 Interventions

* 60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4 * Followed by 300 mcg of CH505TF chTrimer, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered at months 6 and 8.

Group VI: Part B - Group 2 Experimental Treatment 3 Interventions

* 60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 1.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4 * Followed by 300 mcg of CH505TF chTrimer, admixed with 1.0 mcg of ACU-026-001-1 adjuvant to be administered at months 6 and 8.

Group VII: Part A - Group 1 Experimental Treatment 1 Intervention

• 60 mcg of CD4BS CH505M5 Pr-NP1, to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Access to Advanced Health Institute (AAHI)

Collaborator

Trials

30

Recruited

1,700+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10552807/

Progress with induction of HIV broadly neutralizing ... Success of induction of CD4bs precursors in humans in the IAVI G001 clinical trial [72▪▪] and success in inducing both MPER bnAb precursors and mature ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06267872

Study Details | NCT06267872 | A Clinical Trial in Adult ... A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by ...

3. journals.lww.com journals.lww.com/co-hivandaids/fulltext/2023/11000/progress_with_induction_of_hiv_broadly.5.aspx

Progress with induction of HIV broadly neutralizing... Success of induction of CD4bs precursors in humans in the IAVI G001 clinical trial [72▪▪] and success in inducing both MPER bnAb precursors and mature ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10881492/

Exploring synergies between B- and T-cell vaccine ... The goal of this workshop was to review data on leading vaccine candidates and to discuss the best strategies for combining these approaches to optimize ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0944501325001855

Targeting HIV-1 immune escape mechanisms This review discusses the principal mechanisms of HIV-1 immune evasion and highlights the latest progress in vaccine research.

6. vumc.org vumc.org/hiv-vaccine-program/current-studies

Current Studies | Vanderbilt HIV Vaccine Program HVTN 309: A phase 1 clinical trial in adult participants without HIV and in overall good health to evaluate the safety and immunogenicity of CD4BS CH505M5 Pr- ...

7. synapse.patsnap.com synapse.patsnap.com/drug/cbfdee053fb74bf5ac4f2581d49a8e5e

CD4BS CH505M5 Pr-NP1(National Institute of Allergy & ... A Phase 1 Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 ...