Study to Evaluate the Safety and Immunogenicity of an Oral HIV Vaccine in Healthy, HIV-uninfected Adults

NCT02771730 | Terminated Phase 1 DMC

• 2 other identifiers: HVTN 1102010-0751
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus vector. The adenovirus vector may help the vaccines stimulate an immune response. Researchers want to see how the immune system will respond to these vaccines as well as if they are safe to give to people. Participants cannot get HIV from these vaccines. However, researchers also want to see if the vaccine's adenovirus is contagious. Adenoviruses cause cold symptoms or mild eye infections, therefore household and intimate contacts will be asked to participate as well.

Conditions

Healthy Volunteer; HIV Vaccine

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety of the Ad4-mgag and Ad4-EnvC150 vaccines in humans when administered via the oral route in combination with an AIDSVAX® B/E boost.

  To evaluate vaccine tolerability in terms of local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and AEs and SAEs.

  14 months

Study Arms (5)

Vaccine A

EXPERIMENTAL

Receive Ad4-mgag three times at 0,2,and 6 months with a boost at 8months

Biological: Ad4-mgag; Biological: AIDSVAX B/E

Vaccine B

EXPERIMENTAL

Receive Ad4-EnvC150 three times at 0,2,and 6 months with a boost at 8 months

Biological: Ad4-EnvC150; Biological: AIDSVAX B/E

Vaccine A & B

EXPERIMENTAL

Receive both Ad4-mgag and Ad4-EnvC150 three times at 0,2,and 6 months with a boost at 8 months

Biological: Ad4-mgag; Biological: Ad4-EnvC150; Biological: AIDSVAX B/E

Placebo

PLACEBO COMPARATOR

Receive placebo three times at 0,2,and 6 months with a boost at 8 months

Other: Placebo Comparator; Biological: AIDSVAX B/E

Vaccine A & B (previously received study vaccine)

EXPERIMENTAL

People who have previously had a study vaccine: Receive both Ad4-mgag and Ad4-EnvC150 three times at 0,2,and 6 months with a boost at 8 months

Biological: Ad4-mgag; Biological: Ad4-EnvC150; Biological: AIDSVAX B/E

Interventions

Ad4-mgag BIOLOGICAL

A live replication-competent Adenovirus type-4 vector encoding a mosaic HIV Gag antigen, delivered orally by enteric-coated capsules.

Vaccine A; Vaccine A & B; Vaccine A & B (previously received study vaccine)

Ad4-EnvC150 BIOLOGICAL

A live replication-competent Adenovirus type-4 vector encoding an HIV clade C Env protein (gp150 1086.C), delivered orally by enteric-coated capsules.

Vaccine A & B; Vaccine A & B (previously received study vaccine); Vaccine B

Placebo Comparator OTHER

Oral sucrose capsules

Placebo

AIDSVAX B/E BIOLOGICAL

300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein adsorbed onto 600 mcg of aluminum hydroxide gel adjuvant, administered intramuscularly (IM).

Placebo; Vaccine A; Vaccine A & B; Vaccine A & B (previously received study vaccine); Vaccine B

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• General and Demographic Criteria
• Age of 18 to 49 years.
• Access to a participating HVTN CRS and willingness to be followed for the planned duration of the study
• Ability and willingness to provide informed consent
• Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
• Willing to be contacted annually after completion of scheduled clinic visits for a total of 3 years following initial study vaccination.
• Agrees not to enroll in another study of an investigational research agent during the study period.
• Good general health as shown by medical history, physical exam, and screening laboratory tests without clinically significant findings within the 8 weeks prior to enrollment
• Willing to provide nasal, rectal, and cervical (for people born female) mucosal secretion samples and throat, nasal and rectal swab samples (see Appendix J)
• HIV-Related Criteria:
• Willingness to receive HIV test results and abide by NIH guidelines for partner notification of positive HIV results
• Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling.
• Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit.
• Hemoglobin ≥ 11.0 g/dL for volunteers who were born female, ≥ 13.0 g/dL for volunteers who were born male
• White blood cell count = 3,300 to 12,000 cells/mm3

You may not qualify if:

• General
• Blood products received within 120 days before first vaccination
• Investigational research agents received within 30 days before first vaccination
• Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: age \> 45, systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, current smoker, known hyperlipidemia
• Intent to participate in another study of an investigational research agent during the planned duration of the HVTN 110 study
• Pregnant, breastfeeding, or planning pregnancy before 28 days following the final vaccination
• Participant whose intimate contacts do not agree to enroll in the study or consent to be tested for VISP.
• Participants who live in the same house or apartment with, have intimate contact with, or care for, any of the following:
• An individual under 18 years or over 65 years of age.
• An individual with known HIV infection
• An immunocompromised or immunosuppressed individual
• An individual with chronic respiratory disease
• A woman who is currently pregnant, breast feeding, or planning a pregnancy during the period of immunization.
• Participants caring for children \<18 years of age.
• Healthcare worker who has direct contact with immunodeficient, unstable, or pediatric patients.

Sponsors & Collaborators

• Emergent BioSolutions: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Paxvax

Redwood City, California, 94063, United States

Location

MeSH Terms

Interventions

AIDSVAX B-E

Study Officials

• Sean Bennett, MD

  Emergent BioSolutions

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 13, 2016
• Study Start: March 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)