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Safety and Immune Response to a Recombinant Adenovirus HIV-1 Vaccine in Healthy Adults

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Ad5.ENVA.48 HIV-1 vaccine

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV Seronegativity, HIV Preventive Vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Good general health
Normal hematological, hepatic and renal functions
Demonstrated understanding of study
Willing to receive HIV test results
HIV-1 and -2 uninfected
Hepatitis B surface antigen negative
Anti-hepatitis C virus (anti-HCV) negative antibody or negative HCV PCR if anti-HCV is positive
Adequate contraception. For more information on this criterion can be found in the protocol.

Exclusion Criteria:

HIV vaccines or placebos in prior HIV vaccine trial
Immunosuppressive medications within 168 days prior to first injection. Participants taking corticosteroid nasal spray or topical corticosteroids are not excluded.
Blood products within 120 days prior to first injection
Immunoglobulin within 60 days prior to first injection
Investigational agents within 30 days prior to first injections
Live attenuated vaccine within 30 days prior to first injection
Any vaccine that is not a live attenuated vaccine within 14 days prior to first injection
Any clinically significant medical condition that, in the opinion of the investigator, may interfere with the study
Any medical, psychiatric, occupational, or social condition or responsibility that, in the opinion of the investigator, would interfere with the study
Serious adverse reaction to vaccines. Participants who had a nonanaphylactic adverse reaction to pertussis vaccine as a child are not excluded.
Known autoimmune disease
Known immunodeficiency
Asthma other than mild, well-controlled asthma
Diabetes mellitus type 1 or 2
Thyroidectomy or thyroid disease in the12 months prior to study entry
Angioedema in the 3 years prior to study entry
Hypertension. More information on this criterion can be found in the protocol.
Body mass index (BMI) of 40 or higher OR BMI of 35 or greater, if other cardiovascular risk factors. More information on this criterion can be found in the protocol.
Bleeding disorder
Malignancy, unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period
Seizure disorder or occurrence of seizure in the 3 years prior to study entry. Participants who have not required medications or had a seizure for prior 3 years are not excluded.
Absence of spleen
Individuals at high-risk of acquiring HIV infection
Presence of pre-existing neutralizing antibodies for Adenovirus 5 or 48
Pregnancy or breastfeeding

Sites / Locations

Brigham and Women's Hosp. Novel Adenoviral Vector Prophylactic HIV Vaccine Non-Network CRS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm Description

3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10^9 virus particles (VP) given at Days 0, 28, and 168

3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10^10 virus particles (VP) given at Days 0, 28, and 168

3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10^11 virus particles (VP) given at Days 0, 28, and 168

1 injection of rAd5.ENVA.48 HIV-1 vaccine or placebo at a dose determined by the safety data from Arms 1, 2 and 3 given at Day 0.

Outcomes

Primary Outcome Measures

Local and systemic adverse reactions

Secondary Outcome Measures

Humoral Immune response

Cell mediated immunity

Genotyping

Full Information

NCT ID

NCT00695877

First Posted

June 10, 2008

Last Updated

October 28, 2021

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

1. Study Identification

Unique Protocol Identification Number

NCT00695877

Brief Title

Safety and Immune Response to a Recombinant Adenovirus HIV-1 Vaccine in Healthy Adults

Official Title

A Phase I Randomized, Double-blind, Placebo Controlled Dose Escalation Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Adenovirus Serotype 5 HVR48 HIV-1 Vaccine (Ad5HVR48.ENVA.01) in Healthy, HIV-1 Uninfected Adults (Ad5HVR48.ENVA.01 (rAd5HVR48) HIV-1/IPCAVD-002 Vaccine Study)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

February 8, 2009 (Actual)

Primary Completion Date

December 11, 2012 (Actual)

Study Completion Date

October 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Successful control of the HIV epidemic will require a safe and effective vaccine to be developed. A successful vaccine will need to stimulate a widespread immune response. The purpose of this study is to determine the safety of and immune response to an adenovirus serotype HIV vaccine in HIV uninfected adults.

Detailed Description

Control of the HIV pandemic can only be achieved with the development of a safe and effective preventive HIV vaccine. A vaccine that will prevent HIV infection will elicit a strong immune response from both CD4 and CD8 cells. Recombinant adenovirus serotype vectors have been shown to elicit just such a response. The purpose of this study is to determine the safety and immunogenicity of the recombinant adenovirus serotype 5 preventive HIV-1 vaccine. This study will last 18 to 24 months. Participants will be randomly assigned to one of four arms that will receive vaccine or placebo administered via intramuscular injection. Participants in Arms 1, 2, and 3 will all receive 3 injections. Participants in Arm 4 will receive one injection. For most participants, there will be 10 study visits in this study; for participants in Arm 4, there will be only 7 visits. For Arms 1, 2, and 3, study visits will occur at baseline and on Days 0, 14, 28, 42, 56, 168, 182,196, and 365. Participants in Arms 1, 2, and 3 will receive injections on Days 0, 28, and 168. For participants in Arm 4, study visits will occur at baseline and on Days 0, 14, 28, 56, 168 and 365. Participants in Arm 4 will receive one injection only, on Day 0. Participants will be asked to record their temperature and other side effects in a symptom log for 3 days after each injection. Risk reduction/pregnancy prevention counseling and physical exams will occur at all visits. At most visits, blood, urine, and oral swab collection will occur. Samples collected will be stored for future testing. HIV testing and pregnancy testing will occur at select visits. At Years 2, 3, 4, and 5, participants will be followed-up by telephone, e-mail, or study visit to collect vital status, and information about any development of significant disability or incapacity, hospitalizations, or congenital anomalies. At these follow-up visits, blood collection will be optional.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV Seronegativity, HIV Preventive Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10^9 virus particles (VP) given at Days 0, 28, and 168

Arm Title

Arm Type

Experimental

Arm Description

3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10^10 virus particles (VP) given at Days 0, 28, and 168

Arm Title

Arm Type

Experimental

Arm Description

3 injections of rAd5.ENVA.48 HIV-1 vaccine or placebo at 1 x 10^11 virus particles (VP) given at Days 0, 28, and 168

Arm Title

Arm Type

Experimental

Arm Description

1 injection of rAd5.ENVA.48 HIV-1 vaccine or placebo at a dose determined by the safety data from Arms 1, 2 and 3 given at Day 0.

Intervention Type

Biological

Intervention Name(s)

Ad5.ENVA.48 HIV-1 vaccine

Intervention Description

Recombinant adenovirus serotype 5 HIV-1 vaccine

Primary Outcome Measure Information:

Title

Local and systemic adverse reactions

Time Frame

Throughout study

Secondary Outcome Measure Information:

Title

Humoral Immune response

Time Frame

Throughout study

Title

Cell mediated immunity

Time Frame

Throughout study

Title

Genotyping

Time Frame

Throughout study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Good general health Normal hematological, hepatic and renal functions Demonstrated understanding of study Willing to receive HIV test results HIV-1 and -2 uninfected Hepatitis B surface antigen negative Anti-hepatitis C virus (anti-HCV) negative antibody or negative HCV PCR if anti-HCV is positive Adequate contraception. For more information on this criterion can be found in the protocol. Exclusion Criteria: HIV vaccines or placebos in prior HIV vaccine trial Immunosuppressive medications within 168 days prior to first injection. Participants taking corticosteroid nasal spray or topical corticosteroids are not excluded. Blood products within 120 days prior to first injection Immunoglobulin within 60 days prior to first injection Investigational agents within 30 days prior to first injections Live attenuated vaccine within 30 days prior to first injection Any vaccine that is not a live attenuated vaccine within 14 days prior to first injection Any clinically significant medical condition that, in the opinion of the investigator, may interfere with the study Any medical, psychiatric, occupational, or social condition or responsibility that, in the opinion of the investigator, would interfere with the study Serious adverse reaction to vaccines. Participants who had a nonanaphylactic adverse reaction to pertussis vaccine as a child are not excluded. Known autoimmune disease Known immunodeficiency Asthma other than mild, well-controlled asthma Diabetes mellitus type 1 or 2 Thyroidectomy or thyroid disease in the12 months prior to study entry Angioedema in the 3 years prior to study entry Hypertension. More information on this criterion can be found in the protocol. Body mass index (BMI) of 40 or higher OR BMI of 35 or greater, if other cardiovascular risk factors. More information on this criterion can be found in the protocol. Bleeding disorder Malignancy, unless it has been surgically removed and, in the opinion of the investigator, is not likely to recur during the study period Seizure disorder or occurrence of seizure in the 3 years prior to study entry. Participants who have not required medications or had a seizure for prior 3 years are not excluded. Absence of spleen Individuals at high-risk of acquiring HIV infection Presence of pre-existing neutralizing antibodies for Adenovirus 5 or 48 Pregnancy or breastfeeding

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lindsey Baden, MD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Dan Barouch, MD

Organizational Affiliation

Beth Israel Deaconess Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Brigham and Women's Hosp. Novel Adenoviral Vector Prophylactic HIV Vaccine Non-Network CRS

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18433307

Citation

Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, Lalezari J, Santiago S, Marmor M, Lally M, Novak RM, Brown SJ, Kulkarni P, Dubey SA, Kierstead LS, Casimiro DR, Mogg R, DiNubile MJ, Shiver JW, Leavitt RY, Robertson MN, Mehrotra DV, Quirk E; Merck V520-016 Study Group. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis. 2008 Jun 1;46(11):1769-81. doi: 10.1086/587993.

Results Reference

background

PubMed Identifier

18446196

Citation

Stevens W, Kamali A, Karita E, Anzala O, Sanders EJ, Jaoko W, Kaleebu P, Mulenga J, Dally L, Fast P, Gilmour J, Farah B, Birungi J, Hughes P, Manigart O, Stevens G, Yates S, Thomson H, von Lieven A, Krebs M, Price MA, Stoll-Johnson L, Ketter N. Baseline morbidity in 2,990 adult African volunteers recruited to characterize laboratory reference intervals for future HIV vaccine clinical trials. PLoS One. 2008 Apr 30;3(4):e2043. doi: 10.1371/journal.pone.0002043.

Results Reference

background

PubMed Identifier

24719474

Citation

Baden LR, Walsh SR, Seaman MS, Johnson JA, Tucker RP, Kleinjan JA, Gothing JA, Engelson BA, Carey BR, Oza A, Bajimaya S, Peter L, Bleckwehl C, Abbink P, Pau MG, Weijtens M, Kunchai M, Swann EM, Wolff M, Dolin R, Barouch DH. First-in-human evaluation of a hexon chimeric adenovirus vector expressing HIV-1 Env (IPCAVD 002). J Infect Dis. 2014 Oct 1;210(7):1052-61. doi: 10.1093/infdis/jiu217. Epub 2014 Apr 8.

Results Reference

derived

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Safety and Immune Response to a Recombinant Adenovirus HIV-1 Vaccine in Healthy Adults

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