NCT01989533

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2013

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

November 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2019

Completed
Last Updated

December 17, 2019

Status Verified

April 24, 2019

Enrollment Period

5.4 years

First QC Date

November 19, 2013

Last Update Submit

December 14, 2019

Conditions

Vaccine Response

Keywords

HIV VaccineHealthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety of the Ad4-mgag and Ad4-EnvC150 vaccines in humans when administered via the oral or intranasal route.

    Safety

    Ongoing

Secondary Outcomes (1)

  • To evaluate the immunogenicity of the Ad4- mgag and Ad4-EnvC150 vaccines in humans when administered via the oral or intranasal routes in humans

    Ongoing

Study Arms (4)

A

PLACEBO COMPARATOR

Placebo controlled (blinded)

Biological: Ad4-mgagBiological: Ad4-EnvC150Biological: gp 120 Protein Boost

B

ACTIVE COMPARATOR

Intranasal Randomized

Biological: Ad4-mgagBiological: Ad4-EnvC150Biological: gp 120 Protein Boost

C

EXPERIMENTAL

Oral Open label

Biological: Ad4-mgagBiological: Ad4-EnvC150Biological: gp 120 Protein Boost

D

EXPERIMENTAL

Intranasal Open Label

Biological: Ad4-mgagBiological: Ad4-EnvC150Biological: gp 120 Protein Boost

Interventions

Ad4-mgagBIOLOGICAL

Ad4 live virus vaccine with an HIV insert

ABCD
Ad4-EnvC150BIOLOGICAL

Ad4 live virus vaccine with an HIV insert

ABCD
gp 120 Protein BoostBIOLOGICAL

HIV protein boost

ABCD

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All participants (vaccinees, household contacts, and intimate contacts) must meet all of the following criteria:
  • Age 18 to 49 years for vaccinees. Age 18 to 65 years for household and intimate contacts.
  • Negative FDA-approved HIV test.
  • Able to provide proof of identity to the acceptance of the Principal Investigator or designee during enrollment.
  • Available and willing to participate in follow-up visits and tests for the duration of the study.
  • Willing to have samples stored for future research.
  • In good general health without clinically significant medical history.
  • Willing to discuss HIV infection risks with the study clinicians, assessed as low risk for HIV infection, amenable to HIV risk reduction counseling, and committed to maintaining behavior consistent with
  • low risk of HIV exposure through the last required clinic visit in the protocol schedule.
  • Negative Beta-HCG pregnancy test for females presumed to be of reproductive potential.
  • A female must meet one of the following criteria:
  • No reproductive potential because of menopause (one year without menses) or because of a hysterectomy, bilateral oophorectomy, or tubal ligation.
  • Participant agrees to be heterosexually inactive or consistently practice contraception at least 21 days prior to and 28 days following each vaccination. Acceptable methods of contraception include the following:
  • condoms, male or female, with a spermicide.
  • diaphragm or cervical cap with spermicide.
  • +21 more criteria

You may not qualify if:

  • A participant (vaccinees, household contacts, and intimate contacts) will be excluded if they have the following:
  • \. Any condition that, in the investigator s judgement, places the subject at undue risk by participating in the study.
  • History of any prior disease or therapy which would affect immune or pulmonary function.
  • Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • History of radiation therapy or cytotoxic/cancer chemotherapy.
  • History of diabetes mellitus.
  • Immunodeficiency or autoimmune disease.
  • Acute infection or a recent (within 6 months) history of chronic infection suggestive of immunodeficiency.
  • Taking any medication which may affect immune function, except participants may be taking low doses of nonprescription strength NSAIDS (including e.g. ibuprofen or aspirin) or acetaminophen.
  • Chronic respiratory disorders including asthma, emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent or ongoing respiratory tract infection. If a respiratory disorder is transient, defer immunization but do not exclude the participant.
  • Active Hepatitis B or C infection (i.e. Hepatitis B or C positive serology with the presence of virus antigen or DNA. Ongoing viral replication will be confirmed by a Hepatitis B antigen or Hepatitis C viral load).
  • Female of child-bearing potential who is breast-feeding or planning pregnancy during the 28 days following vaccination.
  • Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with or serve as a contraindication to receipt of live virus vaccine, protocol adherence, or a participant s ability to give informed consent.
  • Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment.
  • Participants that live in the same house or apartment with any of the following will be excluded:
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Boyaka PN, Tafaro A, Fischer R, Leppla SH, Fujihashi K, McGhee JR. Effective mucosal immunity to anthrax: neutralizing antibodies and Th cell responses following nasal immunization with protective antigen. J Immunol. 2003 Jun 1;170(11):5636-43. doi: 10.4049/jimmunol.170.11.5636.

    PMID: 12759444BACKGROUND

  • Brandt CD, Kim HW, Vargosko AJ, Jeffries BC, Arrobio JO, Rindge B, Parrott RH, Chanock RM. Infections in 18,000 infants and children in a controlled study of respiratory tract disease. I. Adenovirus pathogenicity in relation to serologic type and illness syndrome. Am J Epidemiol. 1969 Dec;90(6):484-500. doi: 10.1093/oxfordjournals.aje.a121094. No abstract available.

    PMID: 4312064BACKGROUND

  • Braucher DR, Henningson JN, Loving CL, Vincent AL, Kim E, Steitz J, Gambotto AA, Kehrli ME Jr. Intranasal vaccination with replication-defective adenovirus type 5 encoding influenza virus hemagglutinin elicits protective immunity to homologous challenge and partial protection to heterologous challenge in pigs. Clin Vaccine Immunol. 2012 Nov;19(11):1722-9. doi: 10.1128/CVI.00315-12. Epub 2012 Aug 29.

    PMID: 22933397BACKGROUND

Study Officials

  • Mark Connors, M.D.

    National Institute of Allergy and Infectious Diseases (NIAID)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 21, 2013

Study Start

November 19, 2013

Primary Completion

April 8, 2019

Study Completion

April 8, 2019

Last Updated

December 17, 2019

Record last verified: 2019-04-24

Locations

US(1)