HealthyPhase 1NCT00009685
HIV-1 Vaccine Test in Uninfected Adult Volunteers
A Phase 1 study testing VRC4302 in people with Healthy and HIV Seronegativity, 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 will examine whether it causes an immune response to HIV virus proteins. A vaccine is given to try to create resistance or immunity to a disease or infection. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy, HIV Seronegativity
- What is being tested?
- VRC4302
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Mar 2005
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must be between 18-60 years of age (no more than 10% of the volunteers to be over 50).
- Male and female subjects are eligible. (For female participants: negative pregnancy test at the screening visit; for both male and female participants: agree to practice abstinence or use barrier contraception from the date of the first vaccination until 3 months after the final immunization.)
- No significant findings on medical history, physical exam or screening lab studies as determined by clinic personnel
- Willing to identify HIV infection risks and amenable to risk reduction counceling.
- All subjects must understand the basis of transmission of HIV and agree to abstain from higher risk behavior for HIV infection.
- Normal complete blood count and differential defined as:
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- Hematocrit greater than or equal to 34 percent for women and 38 percent for men; White blood cell count greater than or equal to 3,500/mm(3) and less than or equal to 10,000/mm(3) with no significant findings on differential; Total lymphocyte count greater than or equal to 800 cells/mm(3); Absolute CD4 count greater than or equal 400 cells/mm(3); Platelets 150,000-550,000 cells/cm(3).
- Normal ALT and AST (less than or equal to 1.5 times institutional upper limit) and creatinine (less than or equal to 1.6 mg/dl).
- Normal or low positive ANA titer (1 to 3 EU) if there is no clinical evidence of underlying disorders that are associated with a positive ANA, if no first degree relative has an autoimmune disease, and if anti-ENA antibodies are negative
- Negative anti-dsDNA antibodies
- Normal IgG levels
- CPK less or equal to 2 times institutional upper limit
- No significant findings on urinalysis
- No significant findings on chest x-ray
- Negative RPR (unless determined to be a false positive or a positive result is due to a prior-greater than 6 month-treated infection)
- Negative for Hepatitis B surface antigen and anti-hepatitis C antibody
- Negative for HIV by ELISA and DNA-PCR (below the limit of detection of the assay used) within 4 weeks of immunization (note that if a potential subject will not be allowed on study until further studies--potentially including repeat ELISAs, RT-PCR and DNA PCR--demonstrate that the subject is not infected with HIV)
- Availability for follow-up for planned duration of the study (12 months)
- Give informed consent by signing the Institutional Review Board (IRB) approved informed consent form(s)
- Willingness to have samples stored and to have HLA testing
Who cannot join
- History of immunodeficiency, chronic illness, malignancy, autoimmune disease, or use of immunosuppressive medications. Individuals with a history of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure
- Medical or psychiatric conditions which preclude subject compliance with the protocol.
- Evidence of active drug or alcohol abuse
- Tested positive to HIV at any time.
- Live attenuated vaccines (including but not limited to measles, mumps, rubella and BCG) within 60 days of study (note: medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunization)
- Use of experimental agents within 30 days prior to study
Show all 15Show fewer
- Receipt of blood products or immunoglobulin in the past 6 months
- Any history of anaphylaxis or history of other serious adverse reactions to vaccines
- Prior receipt of HIV-1 vaccines
- Pregnant or lactating women
- Acute infectious illnesses within 1 month prior to initiation of immunization
- History of splenectomy
- Seizure disorder. A participant with a remote history (over 3 years) of seizure who have not received medications for 3 years or over are eligible if: 1. the seizures were febrile seizures under the age of 2; 2. secondary to alcohol withdrawal; or 3. it was a singular seizure.
- Treatment with immunomodulators, except for NSAIDS, within 14 days prior to enrollment
- Skin disease (e.g., eczema, psoriasis) affecting areas of immunization that precludes immunization
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of an HIV-1 DNA Vaccine Encoding a Modified Gag-Pol Protein in Uninfected Adult Volunteers
This study will test the safety of an experimental vaccine against HIV and will examine whether it causes an immune response to HIV virus proteins. A vaccine is 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 two HIV proteins called "gag" and "pol." 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 proteins that may be made from it.
Healthy normal volunteers between 18 and 60 years of age may be eligible for this study. Candidates will provide a medical history, including information on sexual activity and drug use. They will have a physical examination, blood tests, urine test and chest X-ray. All candidates enrolled in the study must use a barrier method of contraception for sexual intercourse from the start of the study until 3 months after the last vaccination.
Read more
Participants will be assigned to one of two treatment groups: one will receive the experimental vaccine; the other will receive a control substance (inactive salt solution). The first five people assigned to the vaccine group will receive the lowest study dose of the vaccine. If this dose is safe, it will be increased three times for the next group of five and then eight times for the last group of five. Each group will have a total of seven people - five will receive the vaccine and two will get the salt solution.
Before the first injection, and possibly the second and third, a catheter (thin plastic tube) will be placed into a vein so that treatment can be given quickly if there is a reaction to the vaccine. 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. For each injection, the volunteer will
- be observed for at least 1 hour after immunization
- record temperature and symptoms, including any effects at the injection site, for 2 days and report them to the clinic staff
- immediately report any side effects to a study physician or nurse.
Volunteers will have physical examinations and laboratory tests at certain times while they receive the vaccine and for a period afterwards. These procedures will require about 14 clinic visits of about 1 to 2 hours each, and up to 6 hours on vaccination days. Blood will be drawn at all visits. Some of the blood will be used for genetic tests, and some will be stored for future tests of the immune system and the body's response to the study vaccine. The study will last about 12 months from the date of the first injection. After it is completed, clinic staff may contact volunteers once or twice a year for at least 3 years to follow up.
Read the detailed description
This is a Phase I randomized, controlled, double-blinded dose escalation study to examine toxicity, dose and immune response of an HIV plasmid DNA vaccine. The vector used in this study has been optimized for improved safety, expression and immunogenicity. We hypothesize that this vaccine will elicit immune responses to HIV. All work will be conducted at the National Institutes of Health.
Healthy, HIV-negative volunteers will be recruited and pre-screened to confirm that they meet all of the eligibility requirements for participation. Educational materials on DNA vaccines will be reviewed with and provided to participants before enrollment into the study. There will be 3 groups of 7 volunteers. Each group will receive a constant dose of the vaccine pGag(del fs)Pol delta PR delta RT delta IN/h (5 people) or a phosphate buffered saline (PBS) control (2 people) by intramuscular inoculation. Once safety has been established, successive groups will receive a higher dose. Study groups will receive three immunizations containing either 0.5 mg (Group 1), 1.5 mg (Group 2), or 4.0 mg (Group 3) of a DNA vaccine. Dose escalation will be initiated 5 weeks after the last volunteer in the previous dose group receives their first inoculation, providing there are no significant toxicities.
Vaccine-related adverse reactions will be evaluated at scheduled study visits and by study participant report. Immune response will be evaluated as described in Appendix II. Specimens to evaluate immunogenicity will be taken at baseline, and at the time points indicated in Appendix VIII. Unless contraindicated, subsequent inoculations using repeat plasmid vaccinations will be given 28 and 56 days after the first vaccinations. The estimated duration for each volunteer to complete immunizations and follow-up is 12 months.
- Conditions
- Healthy, HIV Seronegativity
- Being tested
- VRC4302
- Keywords
- Vaccine, HIV, Codon-Optimized, HIV Vaccine, Healthy Volunteer, HIV-1 DNA Vaccine, HIV Seronegativity, HIV Preventive Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRC4302Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2001 (estimated)
- Study startJan 2001
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- 21 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00009685
- Sponsor's protocol ID
- 010079
- Other IDs
- 01-I-0079
- Status last verified
- Mar 2005
- First submitted
- 2 Feb 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Tighe H, Corr M, Roman M, Raz E. Gene vaccination: plasmid DNA is more than just a blueprint. Immunol Today. 1998 Feb;19(2):89-97. doi: 10.1016/s0167-5699(97)01201-2. No abstract available.
PubMed 9509764Fu TM, Ulmer JB, Caulfield MJ, Deck RR, Friedman A, Wang S, Liu X, Donnelly JJ, Liu MA. Priming of cytotoxic T lymphocytes by DNA vaccines: requirement for professional antigen presenting cells and evidence for antigen transfer from myocytes. Mol Med. 1997 Jun;3(6):362-71.
PubMed 9234241Ulmer JB, Deck RR, Dewitt CM, Donnhly JI, Liu MA. Generation of MHC class I-restricted cytotoxic T lymphocytes by expression of a viral protein in muscle cells: antigen presentation by non-muscle cells. Immunology. 1996 Sep;89(1):59-67. doi: 10.1046/j.1365-2567.1996.d01-718.x.
PubMed 8911141
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an HIV-1 DNA Vaccine Encoding a Modified Gag-Pol Protein in Uninfected Adult Volunteers
- ClinicalTrials.gov ID
- NCT00009685
- Acronym / sponsor ID
- 010079
- Conditions
- Healthy, HIV Seronegativity
- Keywords
- Vaccine, HIV, Codon-Optimized, HIV Vaccine, Healthy Volunteer, HIV-1 DNA Vaccine, HIV Seronegativity, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jan 2001
- Study completion
- Mar 2005
- First posted
- 5 Feb 2001 (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 will examine whether it causes an immune response to HIV virus proteins. A vaccine is 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 two HIV proteins called "gag" and "pol." 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 proteins that may be made from it.
Healthy normal volunteers between 18 and 60 years of age may be eligible for this study. Candidates will provide a medical history, including information on sexual activity and drug use. They will have a physical examination, blood tests, urine test and chest X-ray. All candidates enrolled in the study must use a barrier method of contraception for sexual intercourse from the start of the study until 3 months after the last vaccination.
Participants will be assigned to one of two treatment groups: one will receive the experimental vaccine; the other will receive a control substance (inactive salt solution). The first five people assigned to the vaccine group will receive the lowest study dose of the vaccine. If this dose is safe, it will be increased three times for the next group of five and then eight times for the last group of five. Each group will have a total of seven people - five will receive the vaccine and two will get the salt solution.
Before the first injection, and possibly the second and third, a catheter (thin plastic tube) will be placed into a vein so that treatment can be given quickly if there is a reaction to the vaccine. 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. For each injection, the volunteer will
- be observed for at least 1 hour after immunization
- record temperature and symptoms, including any effects at the injection site, for 2 days and report them to the clinic staff
- immediately report any side effects to a study physician or nurse.
Volunteers will have physical examinations and laboratory tests at certain times while they receive the vaccine and for a period afterwards. These procedures will require about 14 clinic visits of about 1 to 2 hours each, and up to 6 hours on vaccination days. Blood will be drawn at all visits. Some of the blood will be used for genetic tests, and some will be stored for future tests of the immune system and the body's response to the study vaccine. The study will last about 12 months from the date of the first injection. After it is completed, clinic staff may contact volunteers once or twice a year for at least 3 years to follow up.
Detailed description
This is a Phase I randomized, controlled, double-blinded dose escalation study to examine toxicity, dose and immune response of an HIV plasmid DNA vaccine. The vector used in this study has been optimized for improved safety, expression and immunogenicity. We hypothesize that this vaccine will elicit immune responses to HIV. All work will be conducted at the National Institutes of Health.
Healthy, HIV-negative volunteers will be recruited and pre-screened to confirm that they meet all of the eligibility requirements for participation. Educational materials on DNA vaccines will be reviewed with and provided to participants before enrollment into the study. There will be 3 groups of 7 volunteers. Each group will receive a constant dose of the vaccine pGag(del fs)Pol delta PR delta RT delta IN/h (5 people) or a phosphate buffered saline (PBS) control (2 people) by intramuscular inoculation. Once safety has been established, successive groups will receive a higher dose. Study groups will receive three immunizations containing either 0.5 mg (Group 1), 1.5 mg (Group 2), or 4.0 mg (Group 3) of a DNA vaccine. Dose escalation will be initiated 5 weeks after the last volunteer in the previous dose group receives their first inoculation, providing there are no significant toxicities.
Vaccine-related adverse reactions will be evaluated at scheduled study visits and by study participant report. Immune response will be evaluated as described in Appendix II. Specimens to evaluate immunogenicity will be taken at baseline, and at the time points indicated in Appendix VIII. Unless contraindicated, subsequent inoculations using repeat plasmid vaccinations will be given 28 and 56 days after the first vaccinations. The estimated duration for each volunteer to complete immunizations and follow-up is 12 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Participants must be between 18-60 years of age (no more than 10% of the volunteers to be over 50).
- Male and female subjects are eligible. (For female participants: negative pregnancy test at the screening visit; for both male and female participants: agree to practice abstinence or use barrier contraception from the date of the first vaccination until 3 months after the final immunization.)
- No significant findings on medical history, physical exam or screening lab studies as determined by clinic personnel
- Willing to identify HIV infection risks and amenable to risk reduction counceling.
- All subjects must understand the basis of transmission of HIV and agree to abstain from higher risk behavior for HIV infection.
Key exclusion criteria (15 listed)
- History of immunodeficiency, chronic illness, malignancy, autoimmune disease, or use of immunosuppressive medications. Individuals with a history of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure
- Medical or psychiatric conditions which preclude subject compliance with the protocol.
- Evidence of active drug or alcohol abuse
- Tested positive to HIV at any time.
- Live attenuated vaccines (including but not limited to measles, mumps, rubella and BCG) within 60 days of study (note: medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunization)
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 |
|---|---|---|
| VRC4302 | 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 4 Mar 2008.
- Background: PubMed 9509764Tighe H, Corr M, Roman M, Raz E. Gene vaccination: plasmid DNA is more than just a blueprint. Immunol Today. 1998 Feb;19(2):89-97. doi: 10.1016/s0167-5699(97)01201-2. No abstract available.
- Background: PubMed 9234241Fu TM, Ulmer JB, Caulfield MJ, Deck RR, Friedman A, Wang S, Liu X, Donnelly JJ, Liu MA. Priming of cytotoxic T lymphocytes by DNA vaccines: requirement for professional antigen presenting cells and evidence for antigen transfer from myocytes. Mol Med. 1997 Jun;3(6):362-71.
- Background: PubMed 8911141Ulmer JB, Deck RR, Dewitt CM, Donnhly JI, Liu MA. Generation of MHC class I-restricted cytotoxic T lymphocytes by expression of a viral protein in muscle cells: antigen presentation by non-muscle cells. Immunology. 1996 Sep;89(1):59-67. doi: 10.1046/j.1365-2567.1996.d01-718.x.
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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 VRC4302 in people with Healthy and HIV Seronegativity, 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 20 inclusion and 15 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 4 Mar 2008. 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 NCT00009685, which also lists 3 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 4 Mar 2008.