NIH Clinical Research Studies

Protocol Number: 08-I-0171

Active Accrual, Protocols Recruiting New Patients

Title:
A Phase I, Open Label, CT to Evaluate the Safety, Tolerability and Immunogenicity of a Multiclade Recombinant HIV-1 Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP In Uninfected Adults Randomized to Needle or Biojector Methods of Intramuscular Injection
Number:
08-I-0171
Summary:
This study will compare the immune response and side effects of an experimental HIV vaccine given by two different methods of administration - by needle injection or by use of a needle-free device called the Biojector 2000 (Registered Trademark). The vaccine, called VRC-HIVADV014-00-VP, or rAd5, is made using an adenovirus that has been modified to contain DNA that codes for three HIV proteins. It cannot cause HIV or adenoviral infections.

Healthy volunteers who are not infected with the HIV virus may be eligible for this study. Subjects are recruited for two study groups: Group 1 comprises volunteers who are 18 to 50 years old and have never received an HIV vaccine and Group 2 comprises volunteers who are 18 to 55 years old and participated in a prior study in which they received at least one injection of the study rAd5 vaccine.

Subjects in both groups are randomly assigned to receive the vaccine by needle or Biojector 2000 (Registered Trademark) into a muscle in the upper arm. They call a study nurse 2 days after the injection, record their temperature and symptoms on a diary card at home for 5 days after the injection for later review, and visit the clinic two weeks after the injection for a checkup.

The injection is given on the day of enrollment. Additional visits are scheduled at weeks 2, 4, 12 and 24, when subjects are checked for health changes or problems, their use of medications and how they are feeling. Blood samples are collected at all clinic visits. Subjects are tested for HIV at the beginning and end of the study, are asked about their sexual behavior and drug use, and are counseled about HIV risk reduction. Women are tested for pregnancy at the beginning and end of the study.

Participants in Group 2 may undergo apheresis at the 4-week visit. This procedure is done to collect white blood cells for tests to examine the immune response to the vaccine. Blood is collected through a needle in the vein of one arm and directed through a machine that separates the cell components. The white cells are removed and the rest of the blood is returned through the same needle.

Subjects are asked about any social effects they may have experienced from participating in the study. These effects are monitored to make sure participants receive any needed assistance and to learn ways to prevent these problems in the future.

Sponsoring Institute:
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

A participant must meet all of the following criteria:

1. 18 to 50 years old if enrolling into Group 1 or 18 to 55 years old if enrolling into Group 2.

2. HIV vaccine naive if enrolling into Group 1, or receipt of the VRC HIV rAd5 vaccine in a previous study without experiencing a serious adverse event attributed (i.e., definitely, probably, possibly, or probably not related) to the vaccine if enrolling into Group 2.

3. Available for clinical follow-up through Week 24 of the study.

4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.

5. Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly.

6. Able and willing to complete the informed consent process.

7. Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results.

8. Willing to donate blood for sample storage to be used for future research.

9. Willing to discuss HIV infection risks, at low risk of HIV exposure as assessed by behavioral risk interview and defined by category A in the VRC 000 (02-I-0127) screening protocol, and amenable to risk reduction counseling.

10. In good general health without clinically significant medical history.

11. Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) less than or equal to 40 within the 28 days prior to enrollment.

Laboratory Criteria within 28 days prior to enrollment:

12. Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.0 g/dL for men.

13. White blood cells (WBC) = 3,300-12,000 cells/mm(3).

14. Differential either within institutional normal range or accompanied by site physician approval.

15. Total lymphocyte count greater than or equal to 800 cells/mm(3).

16. Alanine aminotransferase (ALT) less than or equal to 1.25 times the upper limit of normal

17. Serum creatinine less than or equal to 1 time the upper limit of normal (less than or equal to 1.3 mg/dL for females; less than or equal to 1.4 mg/dL for males).

18. HIV-uninfected as evidenced by a negative FDA-approved HIV diagnostic blood test if enrolling into Group 1 or negative HIV polymerase chain reaction (PCR) test if enrolling into Group 2

19. Negative hepatitis B surface antigen (HbsAg).

20. Negative anti-HCV (hepatitis C virus antibody) and negative HCV PCR.

Female-Specific Criteria:

21. Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.

22. A female participant must meet any of the following criteria:

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

or

Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and through Week 24 of the study,

or

Participant agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 24 of the study 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, Norplant, Depo-Provera or other FDA-approved contraceptive method

- male partner has previously undergone a vasectomy.

EXCLUSION CRITERIA:

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

Women:

1. Woman who is breast-feeding or planning to become pregnant during the 24 weeks of study participation.

Volunteer has received any of the following substances:

2. Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past three months.

[Note: The following will NOT exclude study participation:

- use of corticosteroid nasal spray for rhinitis;

- topical corticosteroids for an acute uncomplicated dermatitis;

- short-acting beta-agonists in controlled asthmatics; a short course (10 days or less) of corticosteroids for a non-chronic condition completed at least 2 weeks prior to enrollment in this study]

3. Blood products within 120 days prior to HIV screening.

4. Immunoglobulin within 60 days prior to HIV screening.

5. Investigational research agents within 30 days prior to initial study vaccine administration.

6. Live attenuated vaccines within 30 days prior to initial study vaccine administration.

7. Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration.

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. 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. History of thyroidectomy or thyroid disease that required medication within the past 12 months.

14. A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.

15. Idiopathic urticaria within the past two years.

16. Hypertension that is not well controlled by medication or is more than 145/95 at enrollment.

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. Syphilis infection that is active or a positive serology due to a syphilis infection treated less than six months ago.

19. 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.

20. Seizure disorder other than: 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years.

21. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.

22. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years prior to enrollment, history of a suicide plan or attempt.

23. 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.

Special Instructions:
Currently Not Provided
Keywords:
HIV Negative
Healthy
Immunity
Preventive
Virus
Recruitment Keyword(s):
Healthy Volunteer
HV
Condition(s):
HIV Infections
Investigational Drug(s):
VRC-HIVADV014-00-VP
Investigational Device(s):
None
Intervention(s):
Drug: VRC-HIVADV014-00-VP
Supporting Site:
National Institute of Allergy and Infectious Diseases

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):
Osmanov S, Pattou C, Walker N, SchwardlÅ nder B, Esparza J; WHO-UNAIDS Network for HIV Isolation and Characterization. Estimated global distribution and regional spread of HIV-1 genetic subtypes in the year 2000. J Acquir Immune Defic Syndr. 2002 Feb 1; 29(2):184-90.

Hemelaar J, Gouws E, Ghys PD, Osmanov S. Global and regional distribution of HIV-1 genetic subtypes and recombinants in 2004.AIDS. 2006 Oct 24;20(16):W13-23.

Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Gu L, Martin JE, Novik L, Chakrabarti BK, Butman BT, Gall JG, King CR, Andrews CA, Sheets R, Gomez PL, Mascola JR, Nabel GJ, Graham BS; Vaccine Research Center 006 Study Team. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector.J Infect Dis. 2006 Dec 15;194(12):1638-49. Epub 2006 Nov 8.

Active Accrual, Protocols Recruiting New Patients

If you have:


Command Menu Bar

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home


Clinical Center LogoNational Institutes of Health Clinical Center Bethesda, Maryland 20892. Last update: 09/16/2008
Search The Studies Help Questions