A Clinical Trial to Look at the Safety and Immune Responses of the RNA-based Vaccine BNT168 in Adults Living With or Without HIV

NCT07698600 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: BNT168-01
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will test a new ribonucleic acid (RNA)-based vaccine called BNT168 in adults living both with and without human immunodeficiency virus (HIV), to see how safe it is, how well it triggers the body's immune response and how it affects the amount of virus in the body.

Conditions

HIV -1 Infection

Keywords

HIV (human immunodeficiency virus); combination antiretroviral therapy (cART); Acquired immunodeficiency syndrome (AIDS); Ribonucleic acid (RNA)-based vaccine

Outcome Measures

Primary Outcomes (5)

• Occurrence of at least one adverse event

  In PLWOH and PLWH. By cohort and pooled placebo.

  From dosing through 28 days after each IMP dose

• Occurrence of at least one serious adverse event

  In PLWOH and PLWH. By cohort and pooled placebo.

  From Dose 1 through the end of study (up to 12 months)

• Occurrence of at least one adverse event of special interest

  In PLWOH and PLWH. By cohort and pooled placebo.

  From Dose 1 through the end of study (up to 12 months)

• Occurrence of at least one solicited local reaction (pain, erythema/redness, swelling) at the IMP injection site

  In PLWOH and PLWH. By cohort and pooled placebo. From dosing through 7 days after each IMP dose.

  Up to 7 days after each IMP dose

• Occurrence of at least one solicited systemic event (vomiting, diarrhea, headache, fatigue/tiredness, myalgia/muscle pain, fever)

  In PLWOH and PLWH. By cohort and pooled placebo. From dosing through 7 days after each IMP dose.

  Up to 7 days after each IMP dose

Secondary Outcomes (11)

• Occurrence of cytokine positive cluster of differentiation (CD) 4+ T cells

  Up to 7 days post-Dose 2, 3 and/or 4

• Occurrence of cytokine positive CD8+ T cells

  Up to 7 days post-Dose 2, 3 and/or 4

• Occurrence of proliferating CD8+ T cell responses (measured by carboxifluorescein diacetate succinimidyl ester)

  At 28 days post-Dose 2, 3 and/or 4

• Magnitude of CD4+ T cell counts from ATI start through cART restart

  Up to 168 days post ATI start

• Change in CD4+ T cell count from ATI start to cART restart and end of study

  Up to 168 days post ATI start

Study Arms (7)

A1 in PLWOH - BNT168 dose level 1

EXPERIMENTAL

Biological: BNT168

A2 in PLWOH - BNT168 dose level 2

EXPERIMENTAL

Biological: BNT168

A3 in PLWOH - BNT168 dose level 3

EXPERIMENTAL

Biological: BNT168

A4 in PLWH - BNT168 dose level 2

EXPERIMENTAL

This cohort will undergo ATI post vaccination

Biological: BNT168

A5 in PLWH - BNT168 dose level 3

EXPERIMENTAL

This cohort will undergo ATI post vaccination

Biological: BNT168

PLWOH - Placebo

PLACEBO COMPARATOR

Other: Placebo

PLWH - Placebo

PLACEBO COMPARATOR

PLWH participants receiving placebo will also undergo ATI post vaccination

Other: Placebo

Interventions

BNT168 BIOLOGICAL

Intramuscular injection to be applied in the deltoid muscle, using the same non-dominant arm for all IMP injections

A1 in PLWOH - BNT168 dose level 1; A2 in PLWOH - BNT168 dose level 2; A3 in PLWOH - BNT168 dose level 3; A4 in PLWH - BNT168 dose level 2; A5 in PLWH - BNT168 dose level 3

Placebo OTHER

Isotonic sodium chloride (NaCl) solution (0.9%). Intramuscular injection to be applied in the deltoid muscle, using the same non-dominant arm for all IMP injections

PLWH - Placebo; PLWOH - Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are 18 to 50 years of age inclusive at the time of giving informed consent.
• For PLWOH: Individuals who are HIV-1 and HIV-2 negative at Visit 0. For PLWH: Individuals who are HIV-1 positive and HIV-2 negative at Visit 0.
• Have not received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.
• Are overall healthy as defined in the protocol.
• Individuals who have screening hematology and/or blood chemistry laboratory values as defined in the protocol.
• For PLWOH, starting at Visit 0 and continuously until the last planned visit in this study, individuals who:
• Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher likelihood of acquiring HIV until the End of Study Visit.
• Agree to discuss HIV disease risks.
• Agree to HIV infection risk reduction counseling.
• For PLWH, individuals who:
• Have been on stable continuous cART for at least 12 months (defined as no interruptions longer than 14 continuous days) and with no changes in the components of the cART for at least 12 weeks prior to Visit 1.
• Are not on a non-nucleoside reverse transcriptase inhibitor at screening.
• Have never received lenacapavir and have not received other long-acting antiretroviral therapies in the last 2 years (i.e., intramuscular cabotegravir, cabotegravir-rilpivirine).
• Are willing to undergo HIV transmission risk reduction counseling and to maintain low-risk behavior to protect their partners.
• Have a CD4+ T cell count of ≥500 cells/µL at Visit 0.

You may not qualify if:

• Have had major surgery (e.g., major cardiopulmonary or abdominal operations) as per the investigator's judgment within 4 weeks before Visit 0, or will not have fully recovered from surgery, or have major surgery planned during the time the participants are expected to participate in the study.
• Have an abnormal electrocardiogram at Visit 0 as specified in the protocol.
• Have any existing condition which may affect IMP injection and/or assessment of local reactions, e.g., tattoos, severe scars, etc.
• Have any bleeding diathesis or condition associated with prolonged bleeding that, in the opinion of the investigator, could compromise their wellbeing if they participate in the study.
• Have any current febrile illness (body temperature \>38.0°C/\>100.4°F) or other acute illness within 48 hours prior to IMP administration
• Have any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis, myocardial infarction, congestive heart failure, cardiomyopathy or clinically significant arrhythmias, or any clinically significant cardiac disease per the investigator's judgment.
• Have Grade ≥2 hypertension per Food and Drug Administration toxicity grading scale at screening.
• Have a known or suspected impairment/alteration of immune function, autoimmune disease, or immunodeficiency (except HIV for PLWH), including receipt of any immunostimulant, immunomodulator, immunosuppressive medication, immunoglobulin, or blood/plasma product within 60 days prior to Visit 1 or planned administration during the study. Use of inhaled, intranasal, topical, or locally injected corticosteroids (e.g., intraarticular or intrabursal administration) is acceptable.
• Have received any live vaccines within 28 days prior to Visit 0 or any other vaccines within 14 days prior to Visit 0 or who are planning to receive any vaccine within 28 days of each IMP dose. When possible, standard of care vaccinations should be planned with the study interventions in mind.
• For PLWH: Have a history of opportunistic infections and/or AIDS-defining illnesses according to the US Centers for Disease Control and Prevention 2014 and the National Institutes of Health 2024.
• For PLWOH: Have current untreated or incompletely treated active tuberculosis infection (by history or concerning symptoms). For PLWH: Have current untreated or incompletely treated active tuberculosis infection (by history or concerning symptoms or sputum molecular testing) or current latent tuberculosis infection (by blood interferon-gamma release assay \[IGRA\]). Not excluded: Participants who have a positive IGRA but were fully treated for latent or active tuberculosis infection, per history, review of available records, and per investigator discretion.
• For PLWH: Have untreated or incompletely treated syphilis or genital, oropharyngeal or rectal gonorrhea or chlamydia infection.
• For PLWH: Have a history of multi-class drug resistant HIV-1 infection defined as resistance to three or more classes of HIV drugs.
• Have an estimated glomerular filtration rate of \<45 mL/min/1.73 m2 using the 2021 chronic kidney disease epidemiology creatinine equation.
• History of any serious adverse reactions (including anaphylaxis, respiratory distress, angioedema, or urticaria) to vaccines or to vaccine components such as lipids.

Sponsors & Collaborators

• BioNTech SE: lead

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Central Study Contacts

BioNTech clinical trials patient information

CONTACT

+49 6131 9084; patients@biontech.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share