HIV InfectionsPhase 1NCT04826094

A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya

A Phase 1 study testing Env-C Plasmid DNA, HIV Env gp145 C.6980 protein and Rehydragel® in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: Env-C Plasmid DNA, HIV Env gp145 C.6980 protein and Rehydragel®
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 143 participants
Where: 1 siteKenya
Study dates: 15 Mar 2021to 13 Feb 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy, male and female participant aged 18 to 40 years and available for 26 months.
Must be at low risk for HIV infection per investigator assessment and using the study risk assessment tool.
Must be able to understand and complete the informed consent process.
Must be capable of reading English or Kiswahili.
Must agree to a home visit.
Must complete a Test of Understanding (TOU) before enrollment. Must answer 9 out of 10 questions correctly with a maximum of three attempts.

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Must be in good general health without a clinically significant medical history.
HIV-uninfected per diagnostic algorithm within 45 days of enrollment.
Laboratory values:
Hemoglobin
12.5-18.1 g/dL men
11.0-16.1 g/dL women
White Cell Count
2.7-7.7 x 10³ cells/µL men
3.0-9.1 x 10³ cells/µL women
Platelets:
125-370 10³ cells/µL men
125-444 10³ cells/µL women
ALT and AST: ≤1.25 institutional upper limit of the reference range
Creatinine: ≤1.25 institutional upper limit of the reference range
Urinalysis: (dipstick) for blood and protein less than 1+ and negative glucose Female-Specific Criteria
Negative urine pregnancy test for women at screening, the day of each vaccination, and before any invasive procedure.
Already using and commits to continued use of an adequate birth control method for 45 days before to the first vaccination/placebo vaccination, and for at least 90 days after the final vaccine/placebo vaccination. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted, underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms with spermicide, diaphragms, intrauterine device (IUD), vasectomy in a monogamous partner, or abstinence.
Lymph Node Biopsy Inclusion Criteria
Body mass index (BMI) <35
Platelets >150,000
International normalized ration (INR) <1.2
Verbal report of no NSAIDS/aspirin for 7 days prior.
Negative pregnancy test for participants born female.

Who cannot join

A history of:
Three or more sexual partners in the previous 24 weeks.
Commercial sex work.
Non-adherence to condom use in the absence of a long-term monogamous relationship.
Intravenous drug use in the previous year.
A sexually transmitted infection in the previous 24 weeks.

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Asplenia: any condition resulting in the absence of a functional spleen.
Bleeding disorder diagnosed by a medical doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
Breastfeeding or pregnant (positive pregnancy test) women or planning to become pregnant during the window between study enrollment and three months after the last vaccination visit.
Any past, ongoing, or in remission history of treated or untreated autoimmune disease.
Has known active Hepatitis B virus infection (or positive HBsAg).
Has known active Hepatitis C infection.
History of anaphylaxis or other serious adverse reaction to vaccines or allergies or reactions likely to be exacerbated by any component of the vaccine and placebo, including antibiotics or excipients.
Absolute Neutrophil Count (ANC) <1.0 x 10³ cells/µL.
Participant has received any of the following substances:
Chronic use of therapies that may modify immune response, such as intravenous (IV) immune globulin and systemic corticosteroids (in doses of >20 mg/day prednisone equivalent for periods exceeding 10 days).
The following exceptions are permitted and will not exclude study participation:
Use of corticosteroid nasal spray for rhinitis;
Topical corticosteroids for an acute uncomplicated dermatitis; or
A short course (10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on investigator clinical judgment) at least 2 weeks before enrollment.
Blood products within 120 days before HIV screening.
Immunoglobulins within 30 days before HIV screening.
Any experimental vaccine containing an adjuvant other than aluminum of an adjuvant not approved by the FDA or European Medicines Agency (EMA) as part of a licensed vaccine.
CERVARIX vaccine against HPV (containing AS04)
Receipt of any investigational HIV vaccine, investigational research agents or vaccine within 30 days before enrollment.
Anti-tuberculosis prophylaxis or therapy during the past 90 days before enrollment.
Any psychiatric, social condition, occupational reason, or other responsibility that, in the judgment of the investigator, is a contraindication to protocol compliance or impairs a participant's ability to give informed consent.
Major psychiatric illness and or substance abuse problems during the past 12 months that, in the opinion of the investigator, would preclude participation.
History of atopy or significant skin conditions.
Study site employees who are involved in the protocol and or may have direct access to the study-related area.
Lymph Node Biopsy Exclusion Criteria
History of keloid formation.
History of an inguinal hernia, inguinal canal cryptorchidism, varicocele, hydrocele.
History of inguinal excisional lymph node biopsy.
Final evaluation of eligibility is based on the medical judgment of the investigator. The Protocol Safety Review Team will also remain available to the investigator for consultation if desired.

Trial locations and contacts

1 site in 1 country.

Kenya1 site

Kenya Medical Research Institute/Walter Reed Project, Clinical Research Centre, Off Hospital Road
Kericho

Other trials in Kenya

About this study

Official title: A Randomized, Double-Blind Phase 1 Trial to Evaluate the Safety and Immunogenicity of Priming With Env-C Plasmid DNA Vaccine Alone, With Different Adjuvants, or With an Adjuvanted HIV Env gp145 C.6980 Protein Vaccine and Boosting With the Adjuvanted HIV Env gp145 C.6980 Protein Vaccine With or Without the Env-C Plasmid DNA Vaccine in Healthy HIV Uninfected Adults in Kenya

This is a study of HIV vaccines. A vaccine is a medical product given to prevent certain diseases. The vaccine may educate the body to form a defensive response to try to prevent the disease from the beginning, or preventing it from taking hold of the body. This defensive response is called the immune response. The experimental vaccines in this study are Env-C Plasmid DNA and HIV Env gp145 C690 protein, given with different adjuvants. An adjuvant is a substance added to vaccines that can help make the vaccine more effective by improving the immune response, or by causing the immune response to last longer than it would without the adjuvant. The adjuvants are mixed with the vaccines and injected into muscle or placed on top of the skin. The HIV vaccines contain a piece of genetic material or a protein copied drom the HIV virus cover (Env), but they do not contain the virus itself. The vaccines cannot cause HIV infection or Acquired Immune Deficiency Syndrome (AIDS).

The purpose of this study is to find out if the study vaccines with adjuvants cause side effects and are tolerable, whether humans respond (develop immune responses) to the vaccines, and how ling the effects of the study vaccines last. The study will also compare the effects of the study vaccines with adjuvants and adjuvant patch to those of placebo injections and placebo patch. The placebo will consist of saline (sterile saltwater) and will look like study vaccines, be given in the same way, but will have no active vaccine or adjuvant in it. A total of 126 participants will take part in the study and each will have up to 26 clinic visits and will be followed-up for a total of 108 weeks.

Read the detailed description

Antibodies are the most commonly recognized correlate of vaccine protection from infection; however the possible protective HIV antibody levels, which were induced by the modestly protective RV144 vaccine regimen with alum, rapidly decayed. Potentially, a novel, highly selective adjuvant combined with the correctly sequenced HIV antigen could slow antibody decay, increase antibody magnitude and induce antibodies of appropriate functional response.

RV460 is an exploratory study that will assess the safety, tolerability, and immunogenicity of a vaccine regimen consisting of priming with an Env-C Plasmid DNA vaccine (with or without novel adjuvants) when given with or without adjuvanted HIV Env gp145 C.6980 protein vaccine and boosting with adjuvanted gp145 C.6980 protein with or without the gp120 DNA vaccine. The study will be carried out in Kericho, Kenya. 126 healthy adults will ben enrolled. Participants will be randomized into one of seven groups which have 15/3 vaccine/placebo recipients per group. Each participant will receive six injections (prim at week 0, 4, 12; boost at week 20, 32 and 56) and will be followed-up for a total of 108 weeks.

Conditions: HIV Infections
Being tested: Env-C Plasmid DNA, HIV Env gp145 C.6980 protein, Rehydragel®, ALF43, dmLT
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Env-C Plasmid DNABiological
2 mg per dose. Administered by intramuscular injection.
HIV Env gp145 C.6980 proteinBiological
100 µg per dose. Administered by intramuscular injection.
Rehydragel®Drug
Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
ALF43Biological
Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
dmLTBiological
Adjuvant. Recombinant double mutant Escherichia coli heat labile toxin. 50 µg per dose. Transcutaneous application (needle-free skin patch). 1 mL diluted dmLT added to gauze pad at site of injection.
Placebo (IM)Drug
0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
Placebo (TCl)Drug
Transcutaneous application (needle-free skin patch). 0.9% sodium chloride (sterile saline) added to gauze pad at site of injection.

Study groups in NCT04826094
Study group	Role	What they receive
Group 1: Vaccine	Experimental	3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56 Receives: Biological: Env-C Plasmid DNA; Biological: HIV Env gp145 C.6980 protein; Drug: Rehydragel®; Drug: Placebo (IM)
Group 2: Vaccine	Experimental	3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56 Receives: Biological: Env-C Plasmid DNA; Biological: HIV Env gp145 C.6980 protein; Drug: Rehydragel®; Biological: ALF43; Drug: Placebo (IM)
Group 3: Vaccine	Experimental	3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56 Receives: Biological: Env-C Plasmid DNA; Biological: HIV Env gp145 C.6980 protein; Drug: Rehydragel®; Biological: dmLT; Drug: Placebo (IM); Drug: Placebo (TCl)
Group 4: Vaccine	Experimental	3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56 Receives: Biological: Env-C Plasmid DNA; Biological: HIV Env gp145 C.6980 protein; Drug: Rehydragel®; Biological: ALF43; Biological: dmLT; Drug: Placebo (IM); Drug: Placebo (TCl)
Group 5: Vaccine	Experimental	3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56 Receives: Biological: Env-C Plasmid DNA; Biological: HIV Env gp145 C.6980 protein; Drug: Rehydragel®; Biological: ALF43; Drug: Placebo (IM)
Group 6: Vaccine	Experimental	3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56 Receives: Biological: Env-C Plasmid DNA; Biological: HIV Env gp145 C.6980 protein; Drug: Rehydragel®; Biological: ALF43; Drug: Placebo (IM)
Group 7: Vaccine	Experimental	3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56 Receives: Biological: Env-C Plasmid DNA; Biological: HIV Env gp145 C.6980 protein; Drug: Rehydragel®; Biological: ALF43; Drug: Placebo (IM)
Pooled Placebo	Placebo comparator	Pooled placebo arm. Receives: Drug: Placebo (TCl)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Incidence (number and percentage of participants) of local reactogenicity events post dose 1 by symptom, maximum severity, and priming dose group
Measured: Day 1-Day 7 Post Vaccination 1
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Incidence (number and percentage of participants) of local reactogenicity events post dose 2 by symptom, maximum severity, and priming dose group
Measured: Day 1-Day 7 Post Vaccination 2
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Incidence (number and percentage of participants) of local reactogenicity events post dose 3 by symptom, maximum severity, and vaccination group.
Measured: Day 1-Day 7 Post Vaccination 3
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Incidence (number and percentage of participants) of local reactogenicity events post dose 4 by symptom, maximum severity, and vaccination group
Measured: Day 1-Day 7 Post Vaccination 4
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Incidence (number and percentage of participants) of local reactogenicity events post dose 5 by symptom, maximum severity, and priming dose group
Measured: Day 1-Day 7 Post Vaccination 5
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Incidence (number and percentage of participants) of local reactogenicity events post dose 6 by symptom, maximum severity, and vaccination group
Measured: Day 1-Day 7 Post Vaccination 6
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 1 by symptom, maximum severity, and priming dose group
Measured: Day 1-Day 7 Post Vaccination 1
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 2 by symptom, maximum severity, and priming dose group
Measured: Day 1-Day 7 Post Vaccination 2
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 3 by symptom, maximum severity, and vaccination group
Measured: Day 1-Day 7 Post Vaccination 3
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 4 by symptom, maximum severity, and vaccination group
Measured: Day 1-Day 7 Post Vaccination 4
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 5 by symptom, maximum severity, and priming dose group
Measured: Day 1-Day 7 Post Vaccination 5
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 6 by symptom, maximum severity, and vaccination group
Measured: Day 1-Day 7 Post Vaccination 6
Number of Related Unsolicited AEs (Outcome 13)
Incidence (number and percentage of participants) of related unsolicited AEs by maximum severity and vaccination group.
Measured: Day 1-Day 728
Number of SAEs (Outcome 14)
Incidence (number and percentage of participants) of SAEs by maximum severity and vaccination group
Measured: Day 1-Day 728

Secondary outcomes (11)

Magnitude of Plasma IgG Binding Antibodies in Response to Differing DNA Priming Regimens
Measured by binding antibody assays.
Measured: Thru Week 105
Durability of Plasma IgG Binding Antibodies in Response to Differing DNA Priming Regimens
Measured by binding antibody assays.
Measured: Thru Week 105
Area Under the Curve (AUC) for Plasma IgG Binding Antibodies in Response to Differing DNA Priming Regimens
Measured by binding antibody assays.
Measured: Thru Week 105
Magnitude of Plasma IgG Binding Antibodies Between Groups With and Without Rehydragel® After HIV Env gp145 C.6980 Protein Boosting
Measured by binding antibody assays.
Measured: Thru Week 105
Durability of Plasma IgG Binding Antibodies Between Groups With and Without Rehydragel® After HIV Env gp145 C.6980 Protein Boosting
Measured by binding antibody assays.
Measured: Thru Week 105
AUC for Plasma IgG Binding Antibodies Between Groups With and Without Rehydragel® After HIV Env gp145 C.6980 Protein Boosting
Measured by binding antibody assays.
Measured: Thru Week 105
Presence of Plasma IgG Binding Antibodies
Functional antibodies assessed using rapid fluorometric Antibody-dependent Cell-Mediated Cytotoxicity (ADCC) Assay, Antibody-dependent Cell-mediated Phagocytosis (ADCP), Antibody-dependent Complement (ADC) activation assays, or other functional assays. Neutralizing antibodies assessed using cell line-based and PBMC assays with a panel of viruses from different HIV subtypes, including A, B, C, D, and other circulating recombinant forms (CRFs) such as AE and AG.
Measured: Thru Week 105
Presence of Plasma IgA Binding Antibodies
Functional antibodies assessed using rapid fluorometric Antibody-dependent Cell-Mediated Cytotoxicity (ADCC) Assay, Antibody-dependent Cell-mediated Phagocytosis (ADCP), Antibody-dependent Complement (ADC) activation assays, or other functional assays. Neutralizing antibodies assessed using cell line-based and PBMC assays with a panel of viruses from different HIV subtypes, including A, B, C, D, and other circulating recombinant forms (CRFs) such as AE and AG.
Measured: Thru Week 105
Types of Cell-mediated Immune Responses
Cryopreserved PBMC and lymph nodes will be stimulated with HIV-1-specific antigens and tested using standard (but not limited to) cellular immune assays which may include but are not limited to Intracellular cytokine Staining, ELISPOT, Lymphoproliferation assays, B-cell analysis, T-follicular helper cell and innate immune cell analysis.
Measured: Thru Week 105
Level of Cell-mediated Immune Responses
Cryopreserved PBMC and lymph nodes will be stimulated with HIV-1-specific antigens and tested using standard (but not limited to) cellular immune assays which may include but are not limited to Intracellular cytokine Staining, ELISPOT, Lymphoproliferation assays, B-cell analysis, T-follicular helper cell and innate immune cell analysis.
Measured: Thru Week 105
Types of Mucosal Humoral Responses
Including, but not limited to, plasma IgG and IgA binding antibodies to HIV Env proteins, IgG and IgA subclass, and functional assays.
Measured: Thru Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202113 Feb 2024

First posted1 Apr 2021
Study start15 Mar 2021
Primary completion13 Feb 2024
Study completion13 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 143 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04826094
Sponsor's protocol ID: RV460
Other IDs: 38608
Status last verified: Mar 2023
First submitted: 30 Mar 2021
Last updated: 26 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind Phase 1 Trial to Evaluate the Safety and Immunogenicity of Priming With Env-C Plasmid DNA Vaccine Alone, With Different Adjuvants, or With an Adjuvanted HIV Env gp145 C.6980 Protein Vaccine and Boosting With the Adjuvanted HIV Env gp145 C.6980 Protein Vaccine With or Without the Env-C Plasmid DNA Vaccine in Healthy HIV Uninfected Adults in Kenya
ClinicalTrials.gov ID: NCT04826094
Acronym / sponsor ID: RV460
Conditions: HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 143 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Collaborators: Walter Reed Army Institute of Research (WRAIR), US Military HIV Research Program, The Emmes Company, LLC
Study start: 15 Mar 2021 (actual)
Primary completion: 13 Feb 2024 (actual)
Study completion: 13 Feb 2024 (actual)
First posted: 1 Apr 2021 (actual)
Results: Posted 26 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Group 1: Vaccine	Experimental	Biological: Env-C Plasmid DNA, Biological: HIV Env gp145 C.6980 protein, Drug: Rehydragel®, Drug: Placebo (IM)3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Group 2: Vaccine	Experimental	Biological: Env-C Plasmid DNA, Biological: HIV Env gp145 C.6980 protein, Drug: Rehydragel®, Biological: ALF43, Drug: Placebo (IM)3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Group 3: Vaccine	Experimental	Biological: Env-C Plasmid DNA, Biological: HIV Env gp145 C.6980 protein, Drug: Rehydragel®, Biological: dmLT, Drug: Placebo (IM), Drug: Placebo (TCl)3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Group 4: Vaccine	Experimental	Biological: Env-C Plasmid DNA, Biological: HIV Env gp145 C.6980 protein, Drug: Rehydragel®, Biological: ALF43, Biological: dmLT, Drug: Placebo (IM), Drug: Placebo (TCl)3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Group 5: Vaccine	Experimental	Biological: Env-C Plasmid DNA, Biological: HIV Env gp145 C.6980 protein, Drug: Rehydragel®, Biological: ALF43, Drug: Placebo (IM)3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Group 6: Vaccine	Experimental	Biological: Env-C Plasmid DNA, Biological: HIV Env gp145 C.6980 protein, Drug: Rehydragel®, Biological: ALF43, Drug: Placebo (IM)3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Group 7: Vaccine	Experimental	Biological: Env-C Plasmid DNA, Biological: HIV Env gp145 C.6980 protein, Drug: Rehydragel®, Biological: ALF43, Drug: Placebo (IM)3 doses of prime vaccination at weeks 0, 4, 12 followed by 3 doses of boost vaccination at weeks 20, 32, 56
Pooled Placebo	Placebo comparator	Drug: Placebo (TCl)Pooled placebo arm.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (29 listed)

Healthy, male and female participant aged 18 to 40 years and available for 26 months.
Must be at low risk for HIV infection per investigator assessment and using the study risk assessment tool.
Must be able to understand and complete the informed consent process.
Must be capable of reading English or Kiswahili.
Must agree to a home visit.

Key exclusion criteria (35 listed)

Three or more sexual partners in the previous 24 weeks.
Commercial sex work.
Non-adherence to condom use in the absence of a long-term monogamous relationship.
Intravenous drug use in the previous year.
A sexually transmitted infection in the previous 24 weeks.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Env-C Plasmid DNA2 mg per dose. Administered by intramuscular injection.	Biological	Group 1: Vaccine, Group 2: Vaccine, Group 3: Vaccine, Group 4: Vaccine, Group 5: Vaccine, Group 6: Vaccine, Group 7: Vaccine
HIV Env gp145 C.6980 protein100 µg per dose. Administered by intramuscular injection.	Biological	Group 1: Vaccine, Group 2: Vaccine, Group 3: Vaccine, Group 4: Vaccine, Group 5: Vaccine, Group 6: Vaccine, Group 7: Vaccine
Rehydragel®Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.	Drug	Group 1: Vaccine, Group 2: Vaccine, Group 3: Vaccine, Group 4: Vaccine, Group 5: Vaccine, Group 6: Vaccine, Group 7: Vaccine
ALF43Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.	Biological	Group 2: Vaccine, Group 4: Vaccine, Group 5: Vaccine, Group 6: Vaccine, Group 7: Vaccine
dmLTAdjuvant. Recombinant double mutant Escherichia coli heat labile toxin. 50 µg per dose. Transcutaneous application (needle-free skin patch). 1 mL diluted dmLT added to gauze pad at site of injection.	Biological	Group 3: Vaccine, Group 4: Vaccine
Placebo (IM)0.9% sodium chloride (sterile saline). Administered by intramuscular injection.	Drug	Group 1: Vaccine, Group 2: Vaccine, Group 3: Vaccine, Group 4: Vaccine, Group 5: Vaccine, Group 6: Vaccine, Group 7: Vaccine
Placebo (TCl)Transcutaneous application (needle-free skin patch). 0.9% sodium chloride (sterile saline) added to gauze pad at site of injection.	Drug	Group 3: Vaccine, Group 4: Vaccine, Pooled Placebo

Primary outcome

Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)
Time frame: Day 1-Day 7 Post Vaccination 1
Incidence (number and percentage of participants) of local reactogenicity events post dose 1 by symptom, maximum severity, and priming dose group
Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)
Time frame: Day 1-Day 7 Post Vaccination 2
Incidence (number and percentage of participants) of local reactogenicity events post dose 2 by symptom, maximum severity, and priming dose group
Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)
Time frame: Day 1-Day 7 Post Vaccination 3
Incidence (number and percentage of participants) of local reactogenicity events post dose 3 by symptom, maximum severity, and vaccination group.
Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)
Time frame: Day 1-Day 7 Post Vaccination 4
Incidence (number and percentage of participants) of local reactogenicity events post dose 4 by symptom, maximum severity, and vaccination group
Number of Solicited Local Events Post Vaccination 5 by Vaccination Group (Outcome 5)
Time frame: Day 1-Day 7 Post Vaccination 5
Incidence (number and percentage of participants) of local reactogenicity events post dose 5 by symptom, maximum severity, and priming dose group
Number of Solicited Local Events Post Vaccination 6 by Vaccination Group (Outcome 6)
Time frame: Day 1-Day 7 Post Vaccination 6
Incidence (number and percentage of participants) of local reactogenicity events post dose 6 by symptom, maximum severity, and vaccination group
Number of Solicited Systemic Events Post Vaccination 1 by Priming Dose Group (Outcome 7)
Time frame: Day 1-Day 7 Post Vaccination 1
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 1 by symptom, maximum severity, and priming dose group
Number of Solicited Systemic Events Post Vaccination 2 by Priming Dose Group (Outcome 8)
Time frame: Day 1-Day 7 Post Vaccination 2
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 2 by symptom, maximum severity, and priming dose group
Number of Solicited Systemic Events Post Vaccination 3 by Priming Dose Group (Outcome 9)
Time frame: Day 1-Day 7 Post Vaccination 3
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 3 by symptom, maximum severity, and vaccination group
Number of Solicited Systemic Events Post Vaccination 4 by Vaccination Group (Outcome 10)
Time frame: Day 1-Day 7 Post Vaccination 4
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 4 by symptom, maximum severity, and vaccination group
Number of Solicited Systemic Events Post Vaccination 5 by Vaccination Group (Outcome 11)
Time frame: Day 1-Day 7 Post Vaccination 5
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 5 by symptom, maximum severity, and priming dose group
Number of Solicited Systemic Events Post Vaccination 6 by Vaccination Group (Outcome 12)
Time frame: Day 1-Day 7 Post Vaccination 6
Incidence (number and percentage of participants) of systemic reactogenicity events post dose 6 by symptom, maximum severity, and vaccination group
Number of Related Unsolicited AEs (Outcome 13)
Time frame: Day 1-Day 728
Incidence (number and percentage of participants) of related unsolicited AEs by maximum severity and vaccination group.
Number of SAEs (Outcome 14)
Time frame: Day 1-Day 728
Incidence (number and percentage of participants) of SAEs by maximum severity and vaccination group

11 secondary outcomes

Magnitude of Plasma IgG Binding Antibodies in Response to Differing DNA Priming Regimens
Time frame: Thru Week 105
Durability of Plasma IgG Binding Antibodies in Response to Differing DNA Priming Regimens
Time frame: Thru Week 105
Area Under the Curve (AUC) for Plasma IgG Binding Antibodies in Response to Differing DNA Priming Regimens
Time frame: Thru Week 105
Magnitude of Plasma IgG Binding Antibodies Between Groups With and Without Rehydragel® After HIV Env gp145 C.6980 Protein Boosting
Time frame: Thru Week 105
Durability of Plasma IgG Binding Antibodies Between Groups With and Without Rehydragel® After HIV Env gp145 C.6980 Protein Boosting
Time frame: Thru Week 105
AUC for Plasma IgG Binding Antibodies Between Groups With and Without Rehydragel® After HIV Env gp145 C.6980 Protein Boosting
Time frame: Thru Week 105
Presence of Plasma IgG Binding Antibodies
Time frame: Thru Week 105
Presence of Plasma IgA Binding Antibodies
Time frame: Thru Week 105
Types of Cell-mediated Immune Responses
Time frame: Thru Week 105
Level of Cell-mediated Immune Responses
Time frame: Thru Week 105
Types of Mucosal Humoral Responses
Time frame: Thru Week 104

Results and safety

Results posted to the registry on 26 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Vaccine	17	13
Group 2: Vaccine	16	14
Group 3: Vaccine	17	15
Group 4: Vaccine	16	15
Group 5: Vaccine	16	13
Group 6: Vaccine	18	12
Group 7: Vaccine	17	14
Pooled Placebo	26	20

Primary outcome: Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1)

Time frame: Day 1-Day 7 Post Vaccination 1. Count of participants. Unit: Participants

Measure	Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone n = 33	Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT n = 32	Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43 n = 33	Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein n = 16	Pooled Placebo n = 23	All Participants Receiving Env-C Plasmid DNA n = 114
Any Solicited Local Reactogenicity Event: None	23	27	25	10	20	85
Any Solicited Local Reactogenicity Event: Mild (Grade 1)	8	4	8	4	3	24
Any Solicited Local Reactogenicity Event: Moderate (Grade 2)	2	1	0	2	0	5
Any Solicited Local Reactogenicity Event: Severe (Grade 3)	0	0	0	0	0	0
Any Solicited Local Reactogenicity Event: Potentially Life-Threatening (Grade 4)	0	0	0	0	0	0
Pain/Tenderness: None	27	28	26	12	20	93
Pain/Tenderness: Mild (Grade 1)	5	3	7	2	3	17
Pain/Tenderness: Moderate (Grade 2)	1	1	0	2	0	4

Population analysed: The safety population includes all participants who received at least one vaccination.

Primary outcome: Number of Solicited Local Events Post Vaccination 2 by Priming Dose Group (Outcome 2)

Time frame: Day 1-Day 7 Post Vaccination 2. Count of participants. Unit: Participants

Measure	Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone n = 30	Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT n = 25	Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43 n = 31	Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein n = 15	Pooled Placebo n = 20	All Participants Receiving Env-C Plasmid DNA n = 101
Any Solicited Local Reactogenicity Event: None	26	19	28	11	18	84
Any Solicited Local Reactogenicity Event: Mild (Grade 1)	4	6	3	4	2	17
Any Solicited Local Reactogenicity Event: Moderate (Grade 2)	0	0	0	0	0	0
Any Solicited Local Reactogenicity Event: Severe (Grade 3)	0	0	0	0	0	0
Any Solicited Local Reactogenicity Event: Potentially Life-Threatening (Grade 4)	0	0	0	0	0	0
Pain/Tenderness: None	27	19	28	11	19	85
Pain/Tenderness: Mild (Grade 1)	3	6	3	4	1	16
Pain/Tenderness: Moderate (Grade 2)	0	0	0	0	0	0

Population analysed: The safety population includes all participants who received at least one vaccination.

Primary outcome: Number of Solicited Local Events Post Vaccination 3 by Priming Dose Group (Outcome 3)

Time frame: Day 1-Day 7 Post Vaccination 3. Count of participants. Unit: Participants

Measure	Priming Dose Group 1: Prime of Env-C Plasmid DNA Alone n = 30	Priming Dose Group 2: Prime of Env-C Plasmid DNA / dmLT n = 24	Priming Dose Group 3: Prime of Env-C Plasmid DNA / ALF43 n = 30	Priming Dose Group 4: Prime of Env-C Plasmid DNA / ALF43 / HIV Env gp145 C.6980 Protein n = 14	Pooled Placebo n = 20	All Participants Receiving Env-C Plasmid DNA n = 98
Any Solicited Local Reactogenicity Event: None	25	23	26	14	19	88
Any Solicited Local Reactogenicity Event: Mild (Grade 1)	5	1	4	0	1	10
Any Solicited Local Reactogenicity Event: Moderate (Grade 2)	0	0	0	0	0	0
Any Solicited Local Reactogenicity Event: Severe (Grade 3)	0	0	0	0	0	0
Any Solicited Local Reactogenicity Event: Potentially Life-Threatening (Grade 4)	0	0	0	0	0	0
Pain/Tenderness: None	25	23	28	14	19	90
Pain/Tenderness: Mild (Grade 1)	5	1	2	0	1	8
Pain/Tenderness: Moderate (Grade 2)	0	0	0	0	0	0

Population analysed: The safety population includes all participants who received at least one vaccination.

Primary outcome: Number of Solicited Local Events Post Vaccination 4 by Vaccination Group (Outcome 4)

Time frame: Day 1-Day 7 Post Vaccination 4. Count of participants. Unit: Participants

Measure	Group 1: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel® n = 15	Group 2: Env-C Plasmid DNA + HIV Env gp145 C.6980 Protein / Rehydragel®/ ALF43 n = 14	Group 3: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 Protein / Rehydragel n = 16	Group 4: Env-C Plasmid DNA + dmLT + HIV Env gp145 C.6980 Protein / Rehydragel® / ALF43 n = 14	Group 5: Env-C Plasmid DNA / ALF43 + HIV Env gp145 C.6980 Protein / Rehydragel® n = 15	Group 6: Env-C Plasmid DNA / ALF43 + HIV Env gp145 C.6980 Protein / Rehydragel® / ALF43 n = 15	Group 7: n = 15	Pooled Placebo n = 20	All Participants Receiving Env-C Plasmid DNA n = 104
Any Solicited Local Reactogenicity Event: None	8	12	9	9	12	14	15	18	79
Any Solicited Local Reactogenicity Event: Mild (Grade 1)	6	2	7	4	3	1	0	2	23
Any Solicited Local Reactogenicity Event: Moderate (Grade 2)	1	0	0	1	0	0	0	0	2
Any Solicited Local Reactogenicity Event: Severe (Grade 3)	0	0	0	0	0	0	0	0	0
Any Solicited Local Reactogenicity Event: Potentially Life-Threatening (Grade 4)	0	0	0	0	0	0	0	0	0
Pain/Tenderness: None	8	12	10	9	12	14	15	18	80
Pain/Tenderness: Mild (Grade 1)	6

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs will be assessed and followed from initial recognition of the AE through end of the protocol defined follow-up period. SAEs will be followed up through resolution even if duration of followup goes beyond the protocol-defined the follow-up period. Adverse Events will be followed through the end of the study, a full 12 months following the last vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: Vaccine	1 of 17 (5.9%)	15 of 17 (88.2%)	0 of 17
Group 2: Vaccine	0 of 16 (0%)	15 of 16 (93.8%)	0 of 16
Group 3: Vaccine	0 of 16 (0%)	14 of 16 (87.5%)	0 of 16
Group 4: Vaccine	0 of 16 (0%)	13 of 16 (81.3%)	0 of 16
Group 5: Vaccine	0 of 16 (0%)	13 of 16 (81.3%)	0 of 16
Group 6: Vaccine	0 of 17 (0%)	13 of 17 (76.5%)	0 of 17
Group 7: Vaccine	0 of 16 (0%)	13 of 16 (81.3%)	0 of 16
Pooled Placebo	0 of 23 (0%)	17 of 23 (73.9%)	0 of 23

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Josphat Kosgei, MBChB, MSc principal investigator

Kenya Medical Research Institute/US Medical Research Directorate-Africa

Christina Polyak, MD study chair

U.S. Military HIV Research Program (MHRP)/Walter Reed Army Institute of Research (WRAIR)

Sandhya Vasan, MD study chair

U.S. Military HIV Research Program (MHRP)/Walter Reed Army Institute of Research (WRAIR)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Solicited Local Events Post Vaccination 1 by Priming Dose Group (Outcome 1) (time frame: Day 1-Day 7 Post Vaccination 1). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04826094.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.