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Immune Responses to Two Experimental HIV Vaccines in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01386489
Recruitment Status : Completed
First Posted : July 1, 2011
Last Update Posted : December 16, 2019
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:


The primary focus of the Vaccine Research Center (VRC) at the NIH is to develop vaccines for HIV/AIDS. The main purpose of this study is to look in detail at the body s immune response to two experimental HIV vaccines currently in development at the VRC. One is known as the rAd5 vaccine and the other is known as the DNA vaccine. These vaccines are made with pieces of manufactured DNA. They do not contain live or killed HIV. It is impossible for study vaccines to give you HIV and they cannot cause you to give HIV to someone else. Both of these experimental vaccines have been given to people before in other research studies. They have not been approved for treating or preventing HIV infection.


The main purpose of this study is to look in detail at the body s immune responses after the experimental HIV vaccines are given and to assess safety of the study vaccines.


Healthy volunteers between the ages of 18 and 50 who are not infected with HIV and who meet the eligibility requirements.


Participants will be screened with a medical history (including questions about sexual history and drug use), physical exam, and blood tests.

The study will have two groups:

<TAB>One group will receive one injection of the rAd5 vaccine, and have 8 clinic visits over 3 months.

<TAB>The second group will have three injections of the DNA vaccine, one injection of the rAd5 vaccine, and have 12 clinic visits over 6 months.

All participants will be asked to provide blood and body fluid samples for testing during the study.

Payment for participation will be provided....

Condition or disease Intervention/treatment Phase
HIV Negative Adaptive Immunity Innate Immunity Biological: VRC-HIVDNA016-00-VP Biological: VRC-HIVADV014-00-VP Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: VRC 016: A Phase 1b Open-Label, Randomized Clinical Trial to Evaluate Early Innate and Adaptive Immune Responses to the Investigational HIV-1 Vaccines: VRC-HIVADV014-00-VP and VRC-HIVDNA016-00-VP in Ad5 Seronegative Healthy Adults
Study Start Date : June 17, 2011
Actual Primary Completion Date : March 9, 2014
Actual Study Completion Date : March 19, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. To describe the kinetics and patterns over the time of innate and adaptive immunologic responses in peripheral blood as well as the pattern of adaptive immune responses at a single timepoint in mucosal samples following vaccination with the rAd5...

Secondary Outcome Measures :
  1. To assess the safety and tolerability of the investigational vaccines.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

A volunteer must meet all of the following criteria:

  1. 18 to 50 years old.
  2. No prior vaccinations with an HIV vaccine or adenoviral vector vaccine.
  3. Available for clinical follow-up for up to 36 weeks after enrollment and committed to follow-up contacts through 144 weeks after enrollment.
  4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
  5. Able and willing to complete the informed consent process.
  6. Willing to donate oral, rectal and genital secretion samples and blood samples for research that will be stored and used for future research.
  7. 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.
  8. In good general health without clinically significant medical history.
  9. Physical examination and laboratory results without clinically significant findings and a weight 50 kg or more with body mass index (BMI) less than or equal to 40 within the 56 days prior to enrollment.

    Laboratory Criteria within 56 days prior to enrollment:

  10. Hemoglobin greater than or equal to 11.2 g/dL for women; greater than or equal to 13.0 g/dL for men.
  11. White blood cells (WBC) = 3,000-12,000 cells/mm(3).
  12. Differential and platelet count either within institutional normal range or accompanied by site physician approval.
  13. Alanine aminotransferase (ALT) less than or equal to 1.75 times upper limit of normal.
  14. HIV-uninfected as evidenced by a negative FDA-approved HIV diagnostic blood test or negative HIV polymerase chain reaction (PCR) test.
  15. Seronegative (defined as less than 1:12) for adenovirus serotype 5 antibody as measured by the NVITAL assay within 84 days (12 weeks) prior to enrollment.

    Male-Specific Criterion:

  16. A male participant must be fully circumcised as assessed by screening physical examination.

    Female-Specific Criteria:

  17. Negative Beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.
  18. A female participant must meet any of the following pregnancy prevention criteria:

No reproductive potential because of menopause [one year without menses] or because of tubal ligation,


Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and through 12 weeks after the last vaccination on the study schedule,


Participant agrees to consistently practice contraception at least 21 days prior to enrollment and through 12 weeks after the last vaccination on the study schedule by one of the following methods:

  • condoms, male or female, with or without a spermicide
  • diaphragm or cervical cap with spermicide
  • intrauterine device
  • contraceptive pills or patch, vaginal ring, injection or other FDA-approved contraceptive method
  • male partner has previously undergone a vasectomy.


A volunteer will be excluded if one or more of the following conditions apply:

  1. Woman who is breast-feeding or planning to become pregnant during study participation.
  2. Woman who is known to not have a cervix or who report having a clinically significant abnormal Pap smear without a subsequent normal result.

    Volunteer has received any of the following substances:

  3. Systemic immunosuppressive medications or cytotoxic medications within the 12 weeks prior to enrollment. [With the exception that a short course (duration of 10 days or less or a single injection) of corticosteroids for a self-limited condition at least 2 weeks prior to enrollment in the study will not exclude study participation.]
  4. Blood products or immunoglobulin within 56 days (8 weeks) prior to enrollment.
  5. Investigational research agents within 28 days (4 weeks) prior to enrollment.
  6. Live attenuated vaccines within 28 days (4 weeks) prior to enrollment.
  7. Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days (2 weeks) prior to enrollment.
  8. Current anti-tuberculosis prophylaxis or therapy.

    Volunteer has a history of any of the following clinically significant conditions:

  9. Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
  10. Clinically significant autoimmune disease or immunodeficiency.
  11. Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.
  12. Diabetes mellitus (type I or II), with the exception of gestational diabetes.
  13. Thyroid disease that is not well controlled.
  14. A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
  15. Generalized idiopathic urticaria within the 1 year prior to enrollment.
  16. Hypertension that is not well controlled by medication.
  17. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
  18. Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study.
  19. Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years.
  20. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
  21. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; disorder requiring lithium; or within five years prior to enrollment, history of a suicide plan or attempt.
  22. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer s ability to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01386489

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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Principal Investigator: Julie E Ledgerwood, D.O. National Institute of Allergy and Infectious Diseases (NIAID)
Layout table for additonal information Identifier: NCT01386489    
Other Study ID Numbers: 110197
First Posted: July 1, 2011    Key Record Dates
Last Update Posted: December 16, 2019
Last Verified: March 19, 2014
Keywords provided by National Institutes of Health Clinical Center (CC):
Mucosal Immunity
Healthy Volunteer