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HIV InfectionsPhase 1NCT00709605

Phase I Study of HIV Adenoviral Vector Vaccine in Healthy Subjects Using Needle or Biojector Injection

A Phase 1 study testing VRC-HIVADV014-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
HIV Infections
What is being tested?
VRC-HIVADV014-00-VP
How many people
31 participants
Where
1 siteUnited States
Study dates
25 Jun 2008to 20 May 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • A participant must meet all of the following criteria:
  • 18 to 50 years old if enrolling into Group 1 or 18 to 55 years old if enrolling into Group 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.
  • Available for clinical follow-up through Week 24 of the study and committed to four years of annual follow-up contact after Week 24.
  • Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
  • Complete an Assessment of Understanding that includes understanding of the STEP Study results prior to enrollment and verbalize understanding of all questions answered incorrectly.
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  • Able and willing to complete the informed consent process.
  • Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results.
  • Willing to donate blood for sample storage to be used for future research.
  • Willing to discuss HIV infection risks, amenable to risk reduction counseling, committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit, and assessed by the clinic staff as being at low risk of HIV infection on the basis of behaviors in the 12 months before enrollment as follows:
  • Sexually abstinent OR
  • Had two or fewer mutually monogamous relationships with partners believed to be HIV-uninfected and who did not use injection drugs, crack cocaine or methamphetamine OR
  • Had two or fewer partners believed to be HIV-uninfected and who did not use injection drugs, crack cocaine or methamphetamine and with whom he/she regularly used condoms for vaginal or anal intercourse.
  • In good general health without clinically significant medical history.
  • Physical examination and laboratory results without clinically significant findings and a 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:
  • Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.0 g/dL for men.
  • White blood cells (WBC) = 3,300-12,000 cells/mm(3).
  • Differential either within institutional normal range or accompanied by site physician approval.
  • Total lymphocyte count greater than or equal to 800 cells/mm(3).
  • Alanine aminotransferase (ALT) less than or equal to 1.25 times the upper limit of normal
  • 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).
  • 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
  • Negative hepatitis B surface antigen (HbsAg).
  • Negative anti-HCV (hepatitis C virus antibody) and negative HCV PCR.
  • Female-Specific Criteria:
  • Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.
  • 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, Depo-Provera or other FDA-approved contraceptive method
  • male partner has previously undergone a vasectomy.

Who cannot join

  • A volunteer will be excluded if one or more of the following conditions apply:
  • Women:
  • 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:
  • Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past three months.
  • [Note: The following will NOT exclude study participation:
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  • 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]
  • Blood products within 112 days (16 weeks) prior to HIV screening.
  • Immunoglobulin within 56 days (8 weeks) prior to HIV screening.
  • Investigational research agents within 28 days (4 weeks) prior to initial study vaccine administration.
  • Live attenuated vaccines within 28 days (4 weeks) prior to initial study vaccine administration.
  • Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days (2 weeks) prior to study vaccine administration.
  • Current anti-tuberculosis prophylaxis or therapy.
  • Volunteer has a history of any of the following clinically significant conditions:
  • Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain.
  • Autoimmune disease or immunodeficiency.
  • 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.
  • Diabetes mellitus (type I or II), with the exception of gestational diabetes.
  • Thyroid disease that is not well-controlled
  • A history of hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema.
  • Generalized idiopathic urticaria within the last 1 years.
  • Hypertension that is not well controlled by medication or is more than 145/95 at enrollment.
  • 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.
  • Within the 12 months prior to enrollment: newly-acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B.
  • 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.
  • Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizure that have not required treatment within the last 3 years.
  • Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen.
  • 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.
  • 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.
  • Within the 12 months prior to enrollment, one or more of the following:
  • excessive daily alcohol use
  • frequent binge drinking
  • chronic marijuana abuse
  • any other illicit drug use

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official 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

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.

Read more

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.

Read the detailed description

Study Design:

VRC 015 will examine safety, tolerability and immune response to the VRC recombinant adenoviral vector serotype 5 vector vaccine, VRC-HIVADV014-00-VP (rAd5), in uninfected subjects who will be randomized to receive the injection either by needle or Biojector injection. The study will include enrollment of rAd5 vaccine-naive subjects, as well as enrollment of rollover subjects who received at least one rAd5 injection in a prior study that included the rAd5 vaccine. The hypothesis is that the rAd5 vaccine will be safe and immunogenic when administered by either needle or Biojector. The primary objectives are to evaluate the safety and tolerability of the rAd5 vaccine at 10(10) PU dosage in the naive and previously vaccinated, uninfected subjects when administered by needle or Biojectors. The secondary objectives include evaluating the HIV-1-specific humoral and T-cell immune responses and adenovirus serotype 5 (Ad5) antibody responses, and social impacts of participation in an HIV vaccine study. Exploratory evaluations include epitope mapping and other immunogenicity evaluations.

Product Description:

The VRC HIV rAd5 vaccine is a recombinant product composed of 4 adenoviral vectors (in a 3:1:1:1 ratio) that encode the HIV-1 Gag/Pol polyprotein from clade B and HIV-1 Env glycoproteins from clades A, B, and C, respectively.

Subjects:

Group 1 will include healthy adults, ages 18-50 years old who are HIV vaccine-naive. Group 2 will include healthy adults, ages 18-55 years old, who are rollover enrollments from a prior study of the VRC HIV rAd5 vaccine.

Study Plan:

Study Group 1 and Group 2 will be simultaneously enrolled. Both groups will be randomized in 1:1 ratio to receive the study injection by needle or Biojector. All study injections will be at a dosage of 10(10) particle units (PU) of rAd5 vaccine delivered into deltoid muscle.

There are more than 100 past study participants who are potentially eligible for Group 2. The study design is based on at least 10 rollover subjects, but allows for additional rollover enrollment of up to 10 more (i.e., Group 2 total n=20) if there is greater than expected interest in participation. The sample for immunogenicity studies collected at Week 4 after vaccination from Group 2 subjects will be obtained by apheresis from those who are willing and eligible for apheresis; otherwise peripheral blood mononuclear cells (PBMCs) will be obtained from 80 mL blood collected by phlebotomy.

Study Duration:

Subjects will be evaluated at 5 or more clinical visits for 24 weeks after the study injection and then followed by annual clinic telephone or mail contact for the subsequent 4 years.

Conditions
HIV Infections
Being tested
VRC-HIVADV014-00-VP
Keywords
HIV Negative, Healthy, Immunity, Preventive, Virus, Healthy Volunteer, HV
Medical subject headings
HIV Infections, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VRC-HIVADV014-00-VPDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety (local and systemic reactogenicity, lab tests, AEs)

Secondary outcomes (1)

  1. Immunogenicity (cellular and humoral immune function assays)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2008 (estimated)
  2. Study start25 Jun 2008
  3. Primary completion20 May 2014
  4. Study completion20 May 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00709605
Sponsor's protocol ID
080171
Other IDs
08-I-0171
Status last verified
20 May 2014
First submitted
28 Jun 2008
Last updated
17 Dec 2019
Results posted
No

Publications

  • Osmanov S, Pattou C, Walker N, Schwardlander 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. doi: 10.1097/00042560-200202010-00013.

    PubMed 11832690

  • 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. doi: 10.1097/01.aids.0000247564.73009.bc.

    PubMed 17053344

  • 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. doi: 10.1086/509258. Epub 2006 Nov 8.

    PubMed 17109335

  • Sarwar UN, Novik L, Enama ME, Plummer SA, Koup RA, Nason MC, Bailer RT, McDermott AB, Roederer M, Mascola JR, Ledgerwood JE, Graham BS; VRC 015 study team. Homologous boosting with adenoviral serotype 5 HIV vaccine (rAd5) vector can boost antibody responses despite preexisting vector-specific immunity in a randomized phase I clinical trial. PLoS One. 2014 Sep 29;9(9):e106240. doi: 10.1371/journal.pone.0106240. eCollection 2014.

    PubMed 25264782

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRC-HIVADV014-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (local and systemic reactogenicity, lab tests, AEs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00709605, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

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