HIV SeronegativityPhase 1NCT00047931
HIV-1 Vaccine Test in Uninfected Adult Volunteers
A Phase 1 study testing VRC-HIVDNA009-00-VP in people with HIV Seronegativity and AIDS Vaccines, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will test the safety of an experimental vaccine against HIV and examine whether it induces an immune response to HIV. A vaccine is a substance given to try to create resistance or immunity to a disease or infection. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- HIV Seronegativity, AIDS Vaccines
- What is being tested?
- VRC-HIVDNA009-00-VP
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2002to 5 May 2009
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A participant must meet all of the following criteria:
- 18 to 40 years old.
- Available for follow-up for the duration of the study (12 months).
- Able to provide proof of identity to the acceptance of the study clinician completing the enrollment process.
- Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly.
- Able and willing to sign the informed consent form.
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- Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results.
- Willing to have blood samples used for future research.
- Willing to discuss HIV infection risks and amenable to risk reduction counseling.
- In good general health without clinically significant medical history.
- Physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment.
- Laboratory Criteria within 28 days prior to enrollment:
- Hematocrit greater than or equal to 34 percent for women; greater than or equal to 38 percent for men.
- WBC count: Non-African Americans equals 3,300-12,000 cells/mm(3); African-Americans equals 2,500-12,000 cells/mm(3) (in the absence of clinical or pathological etiology).
- Differential either within institutional normal range or accompanied by site physician approval.
- Total lymphocyte count: Non-African Americans greater than or equal to 800 cells/mm(3); African Americans greater than or equal to 650 cells/mm(3) (in the absence of clinical or pathological etiology).
- Platelets equals 125,000-550,000/mm(3).
- ALT (SGPT) less than or equal to 1.5 times upper limit of normal.
- Serum creatinine less than or equal to 1.3 mg/dL.
- Normal urinalysis defined as negative glucose, negative or trace protein, and negative or trace hemoglobin (blood).
- Negative FDA-approved HIV blood test.
- Negative Hepatitis B surface antigen.
- Negative anti-HCV or negative HCV PCR if the anti-HCV is positive.
- Female-Specific Criteria:
- Negative beta-HCG pregnancy test for women presumed to be of reproductive potential.
- A female participant 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,
- Or
- -Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and throughout the duration of the study,
- Or
- Participant agrees to consistently practice contraception at least 21 days prior to enrollment and throughout the duration 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, Norplant, or Depo-Provera.
- male partner has previously undergone a vasectomy for which there is documentation.
Who cannot join
- A volunteer will be excluded if one or more of the following conditions apply:
- -Woman who is breast-feeding.
- Volunteer has received any of the following substances:
- HIV vaccines in a prior clinical trial.
- Immunosuppressive or cytotoxic medications within the past six months with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis.
- Blood products within 120 days prior to HIV screening.
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- Immunoglobulin within 60 days prior to HIV screening.
- Live attenuated vaccines within 30 days prior to initial study vaccine administration.
- Investigational research agents within 30 days 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 of study vaccine administration.
- Current anti-TB prophylaxis or therapy.
- Volunteer has a history of any of the following clinically significant conditions:
- Serious adverse reactions to vaccines such as anaphylaxis, 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 including history of thyroidectomy and diagnoses that required medication within the past 12 months.
- Serious angioedema episodes within the previous 3 years or requiring medication in the previous 2 years.
- Hypertension that is not well controlled by medication or is more than 150/100 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.
- Syphilis infection that is active or a positive serology due to a syphilis infection treated less than six months ago.
- 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 under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring prolonged treatment more than 3 years ago.
- 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 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.
- Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgement of the investigator, would interfere with or serve as a contraindication to protocol adherence or a volunteer's ability to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP in Uninfected Adult Volunteers
This study will test the safety of an experimental vaccine against HIV and examine whether it induces an immune response to HIV. A vaccine is a substance given to try to create resistance or immunity to a disease or infection. The vaccine in this study is made from DNA (genetic material) of four HIV proteins called 'gag', 'pol', 'Nef', and 'Env'. Injected into a human, the viral DNA instructs the body to make small amounts of some HIV proteins. This study will see if the body then creates an immune response to these proteins. Study participants cannot catch HIV or AIDS from the DNA vaccine or any proteins made from it.
Healthy normal volunteers between 18 and 40 years of age may be eligible for this study. Candidates will be screened with a medical history, physical examination and blood and urine tests. Women will also have a pregnancy test. Women enrolled in the study must either be infertile (e.g., due to menopause or hysterectomy) or must agree either to abstain from heterosexual sex or to practice birth control for at least 21 days before beginning the study and throughout its duration.
Read more
Participants will be randomly assigned to receive either the experimental vaccine or a placebo (a salt solution that does not contain any active substance) and will be divided into three groups, based on their entry into the study. Of the first seven people enrolled (Group 1), five will receive a 2-mg dose of vaccine and two will receive placebo. If the vaccine is safe at this dose, then in Group 2, five people will receive a 4-mg dose of vaccine and two will receive placebo. If this dose is safe, then in Group 3, thirty people will receive an 8-mg dose of vaccine and six will receive placebo.
All participants will receive three injections in an upper arm muscle-one injection a month for three months-with a needle-less device called a Biojector 2000® (Registered Trademark). At the time of each injection, participants will be observed for at least 1 hour after immunization. At home, they will record their temperature and any symptoms they may experience, including any effects at the injection site, for at least 7 days, or as long as the symptoms remain. If symptoms occur, participants will report them immediately to the clinic staff and, if necessary, come to the clinic for an examination.
Participants will have about 10 clinic visits during the study. Most visits will last about 2 hours; those on vaccination days will last about 4 hours. ...
Read the detailed description
This is a Phase I, randomized, controlled, double-blinded, dose-escalation study to examine tolerability, dose, and immune response of an HIV DNA plasmid vaccine. The hypothesis is that this vaccine will be safe for human administration and elicit immune responses to HIV. The primary objective is to evaluate the safety and tolerability in humans of VRC-HIVDNA009-00-VP and secondary objectives are to evaluate the immunogenicity of the vaccine and social impact of participating in an HIV-1 vaccine trial.
- Conditions
- HIV Seronegativity, AIDS Vaccines
- Being tested
- VRC-HIVDNA009-00-VP
- Keywords
- Healthy, HIV-Negative, Placebo-Controlled, Volunteer, Dose-Escalation, HIV Seronegativity, Healthy Volunteer, HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRC-HIVDNA009-00-VPDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2002 (estimated)
- Study start17 Oct 2002
- Study completion5 May 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV SeronegativityStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Enrolment
- 50 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00047931
- Sponsor's protocol ID
- 030022
- Other IDs
- 03-I-0022
- Status last verified
- 5 May 2009
- First submitted
- 22 Oct 2002
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Graham BS. Clinical trials of HIV vaccines. Annu Rev Med. 2002;53:207-21. doi: 10.1146/annurev.med.53.082901.104035.
PubMed 11818471Bagarazzi ML, Boyer JD, Ayyavoo V, Weiner DB. Nucleic acid-based vaccines as an approach to immunization against human immunodeficiency virus type-1. Curr Top Microbiol Immunol. 1998;226:107-43. doi: 10.1007/978-3-642-80475-5_8. No abstract available.
PubMed 9479839Heilman CA, Baltimore D. HIV vaccines--where are we going? Nat Med. 1998 May;4(5 Suppl):532-4. doi: 10.1038/nm0598supp-532. No abstract available.
PubMed 9585205Graham BS, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Martin JE, McCluskey MM, Chakrabarti BK, Lamoreaux L, Andrews CA, Gomez PL, Mascola JR, Nabel GJ; Vaccine Research Center 004 Study Team. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. J Infect Dis. 2006 Dec 15;194(12):1650-60. doi: 10.1086/509259. Epub 2006 Nov 8.
PubMed 17109336
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA009-00-VP in Uninfected Adult Volunteers
- ClinicalTrials.gov ID
- NCT00047931
- Acronym / sponsor ID
- 030022
- Conditions
- HIV Seronegativity, AIDS Vaccines
- Keywords
- Healthy, HIV-Negative, Placebo-Controlled, Volunteer, Dose-Escalation, HIV Seronegativity, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 17 Oct 2002
- Study completion
- 5 May 2009
- First posted
- 23 Oct 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the safety of an experimental vaccine against HIV and examine whether it induces an immune response to HIV. A vaccine is a substance given to try to create resistance or immunity to a disease or infection. The vaccine in this study is made from DNA (genetic material) of four HIV proteins called 'gag', 'pol', 'Nef', and 'Env'. Injected into a human, the viral DNA instructs the body to make small amounts of some HIV proteins. This study will see if the body then creates an immune response to these proteins. Study participants cannot catch HIV or AIDS from the DNA vaccine or any proteins made from it.
Healthy normal volunteers between 18 and 40 years of age may be eligible for this study. Candidates will be screened with a medical history, physical examination and blood and urine tests. Women will also have a pregnancy test. Women enrolled in the study must either be infertile (e.g., due to menopause or hysterectomy) or must agree either to abstain from heterosexual sex or to practice birth control for at least 21 days before beginning the study and throughout its duration.
Participants will be randomly assigned to receive either the experimental vaccine or a placebo (a salt solution that does not contain any active substance) and will be divided into three groups, based on their entry into the study. Of the first seven people enrolled (Group 1), five will receive a 2-mg dose of vaccine and two will receive placebo. If the vaccine is safe at this dose, then in Group 2, five people will receive a 4-mg dose of vaccine and two will receive placebo. If this dose is safe, then in Group 3, thirty people will receive an 8-mg dose of vaccine and six will receive placebo.
All participants will receive three injections in an upper arm muscle-one injection a month for three months-with a needle-less device called a Biojector 2000® (Registered Trademark). At the time of each injection, participants will be observed for at least 1 hour after immunization. At home, they will record their temperature and any symptoms they may experience, including any effects at the injection site, for at least 7 days, or as long as the symptoms remain. If symptoms occur, participants will report them immediately to the clinic staff and, if necessary, come to the clinic for an examination.
Participants will have about 10 clinic visits during the study. Most visits will last about 2 hours; those on vaccination days will last about 4 hours. ...
Detailed description
This is a Phase I, randomized, controlled, double-blinded, dose-escalation study to examine tolerability, dose, and immune response of an HIV DNA plasmid vaccine. The hypothesis is that this vaccine will be safe for human administration and elicit immune responses to HIV. The primary objective is to evaluate the safety and tolerability in humans of VRC-HIVDNA009-00-VP and secondary objectives are to evaluate the immunogenicity of the vaccine and social impact of participating in an HIV-1 vaccine trial.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (36 listed)
- 18 to 40 years old.
- Available for follow-up for the duration of the study (12 months).
- Able to provide proof of identity to the acceptance of the study clinician completing the enrollment process.
- Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly.
- Able and willing to sign the informed consent form.
Key exclusion criteria (26 listed)
- -Woman who is breast-feeding.
- HIV vaccines in a prior clinical trial.
- Immunosuppressive or cytotoxic medications within the past six months with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis.
- Blood products within 120 days prior to HIV screening.
- Immunoglobulin within 60 days prior to HIV screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VRC-HIVDNA009-00-VP | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 11818471Graham BS. Clinical trials of HIV vaccines. Annu Rev Med. 2002;53:207-21. doi: 10.1146/annurev.med.53.082901.104035.
- Background: PubMed 9479839Bagarazzi ML, Boyer JD, Ayyavoo V, Weiner DB. Nucleic acid-based vaccines as an approach to immunization against human immunodeficiency virus type-1. Curr Top Microbiol Immunol. 1998;226:107-43. doi: 10.1007/978-3-642-80475-5_8. No abstract available.
- Background: PubMed 9585205Heilman CA, Baltimore D. HIV vaccines--where are we going? Nat Med. 1998 May;4(5 Suppl):532-4. doi: 10.1038/nm0598supp-532. No abstract available.
- Derived from this study: PubMed 17109336Graham BS, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Martin JE, McCluskey MM, Chakrabarti BK, Lamoreaux L, Andrews CA, Gomez PL, Mascola JR, Nabel GJ; Vaccine Research Center 004 Study Team. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. J Infect Dis. 2006 Dec 15;194(12):1650-60. doi: 10.1086/509259. Epub 2006 Nov 8.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRC-HIVDNA009-00-VP in people with HIV Seronegativity and AIDS Vaccines, 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 36 inclusion and 26 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 2 Jul 2017. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00047931, 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 2 Jul 2017.