NCT01989533

Study of Safety and Immunogenicity of HIV Vaccines in Healthy Volunteers

Completed Phase 1 Last updated 17 December 2019

What this trial tests

Phase 1 trial testing Ad4-mgag in Vaccine Response in 62 participants. Completed in 8 April 2019.

Timeline

19 November 2013

Primary endpoint
8 April 2019

8 April 2019

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	62
Start date	19 November 2013
Primary completion	8 April 2019
Estimated completion	8 April 2019
Sites	1 location across United States

Drugs / interventions tested

• Ad4-mgag — full drug profile →
• Ad4-EnvC150 — full drug profile →
• gp 120 Protein Boost — full drug profile →

Conditions studied

• Vaccine Response — all drugs for Vaccine Response →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 49, any sex, with Vaccine Response. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- Vaccines create resistance to disease. This study tests experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus as a transporter. Transporters may help vaccines stimulate an immune response against HIV. This means the body works to fight infection. Researchers want to see if different ways of giving the vaccines cause different immune responses. They also want to see if the vaccines adenovirus is contagious. Adenoviruses cause cold symptoms or mild eye infections.

Participants cannot get HIV from these vaccines. But they can get the adenovirus, so their entire household and intimate contacts must participate.

Objective:

\- To test the safety of experimental HIV vaccines.

Eligibility:

\- Healthy adults 18-49 years old.

Design:

* Participants will be screened with medical history, physical exam, and blood and urine tests.
* Participants will receive the vaccine 3 times over 6 months. Each time, they will have a physical exam and blood and urine tests. Samples will be taken from their nose, rectum, and cervix.
* Some participants will receive the vaccine by swallowing 11 capsules with water. Clinic staff will observe them for 1 hour.
* Some participants will receive the vaccine swabbed in their throat. They will get dose 1 at the hospital and stay there for 1 week. They will have medical tests and nose swabs. Doses 2 and 3 will not require a hospital stay.
* Participants will have 7 follow-up visits over 6 months, with a physical exam and blood tests. Samples will be taken from their nose, throat, and rectum.
* Household and intimate contacts will have 4 clinic visits over 8 months, with a physical exam and blood tests.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current approaches to HIV vaccine development: a narrative review.
   Kim J, Vasan S, Kim JH, Ake JA. · · 2021 · cited 62× · PMID 34806296 · DOI 10.1002/jia2.25793
2. Progress in HIV vaccine development.
   Hsu DC, O'Connell RJ. · · 2017 · cited 62× · PMID 28281871 · DOI 10.1080/21645515.2016.1276138
3. New concepts in HIV-1 vaccine development.
   Stephenson KE, D'Couto HT, Barouch DH. · · 2016 · cited 58× · PMID 27268856 · DOI 10.1016/j.coi.2016.05.011
4. First-in-Human Evaluation of the Safety and Immunogenicity of a Recombinant Vesicular Stomatitis Virus Human Immunodeficiency Virus-1 gag Vaccine (HVTN 090).
   Fuchs JD, Frank I, Elizaga ML, Allen M, et al · · 2015 · cited 57× · PMID 26199949 · DOI 10.1093/ofid/ofv082
5. Advances in HIV-1 Vaccine Development.
   Gao Y, McKay PF, Mann JFS. · · 2018 · cited 45× · PMID 29614779 · DOI 10.3390/v10040167
6. Development of Nasal Vaccines and the Associated Challenges.
   Nian X, Zhang J, Zhang J, Huang S, et al · · 2022 · cited 33× · PMID 36297419 · DOI 10.3390/pharmaceutics14101983
7. Advances of Recombinant Adenoviral Vectors in Preclinical and Clinical Applications.
   Scarsella L, Ehrke-Schulz E, Paulussen M, Thal SC, et al · · 2024 · cited 17× · PMID 38543743 · DOI 10.3390/v16030377
8. Exploring HIV Vaccine Progress in the Pre-Clinical and Clinical Setting: From History to Future Prospects.
   Kaur A, Vaccari M. · · 2024 · cited 17× · PMID 38543734 · DOI 10.3390/v16030368