HealthyPhase 1NCT00083330
Safety and Immunogenicity of an HIV Vaccine in Normal Adult Volunteers
A Phase 1 study testing VRC-HIVADV014-00-VP in people with Healthy and HIV Infections, 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 infection and see if it causes an immune response to HIV. The vaccine is given by injection (shot) in the upper arm. It is made from DNA that codes for three HIV proteins. Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Healthy, HIV Infections
- What is being tested?
- VRC-HIVADV014-00-VP
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2004to 1 Oct 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 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A participant must meet all of the following criteria:
- 18 to 44 years old.
- Available for clinical follow-up through Week 24 and telephone or mail contact for an additional 4 years.
- Able to provide proof of identity to the satisfaction 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 complete the informed consent process.
Show all 36Show fewer
- 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 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:
- Hemoglobin is greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men
- WBC is equal to 3,300-12,000 cells/mm(3)
- Differential either within institutional normal range or accompanied by site physician approval
- Total lymphocyte count is greater than or equal to 800 cells/mm(3)
- Platelets is equal to 125,000 - 550,000/mm(3)
- ALT (SGPT) is less than or equal to upper limit of normal
- Serum creatinine is less than or equal to upper limit of normal
- 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
- Female-Specific Criteria:
- Negative Beta-HCG pregnancy test (urine or serum) 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 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 for which there is documentation.
Who cannot join
- A volunteer will be excluded if one or more of the following conditions apply.
- Women:
- 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
Show all 27Show fewer
- Blood products within 120 days prior to HIV screening
- 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.
- History of thyroidectomy or thyroid disease that required medication within the past 12 months.
- Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years.
- Blood pressure that is more than 145/95 at enrollment or hypertension that requires medication.
- 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 treatment within the last 3 years.
- 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, 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.
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 Recombinant Multiclade HIV-1 Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in Uninfected Adult Volunteers
This study will test the safety of an experimental vaccine against HIV infection and see if it causes an immune response to HIV. The vaccine is given by injection (shot) in the upper arm. It is made from DNA that codes for three HIV proteins. The DNA is inserted into an adenovirus that carries it into the muscle cells. The adenovirus normally can cause eye or upper respiratory infections, such as a cold; however, for the vaccine, it has been modified so that it cannot cause illness. Nor can the vaccine cause HIV infection, because it codes for only three of the nine HIV proteins.
Healthy, normal volunteers between 18 and 44 years of age who are not HIV-infected may be eligible for this study. Candidates are screened with a medical history and physical examination and blood and urine tests.
Read more
Participants are randomly assigned to receive either the experimental vaccine or a placebo (an inactive substance that looks like the vaccine). The vaccine or placebo is administered to participants in groups, according to their entry into the study. The first group receives the lowest study dose of vaccine. If this dose is safe, then the second group receives a higher dose. If this dose is also safe, then the third and final group receives the highest study dose. Clinic staff observe the subjects for side effects for 30 minutes after the injection, and subjects keep a diary card for the next 5 days, recording their temperature and any symptoms that may appear. Subjects are contacted by a nurse 2 days after the injection for follow-up.
Participants are seen at the clinic for follow-up visits 1, 2, 4, 12, and 24 weeks after the injection, and then are contacted by telephone for follow-up once a year until 5 years after the injection. The clinic visits include a physical examination, medical history, blood and urine tests, and HIV counseling, as needed. Women have pregnancy tests at the screening evaluation and again at study week 24. All subjects are tested for HIV at screening and at study weeks 12 and 24, and all subjects complete a "social impact questionnaire" at week 24. All subjects are asked questions about their sexual behavior and drug use.
...
Read the detailed description
Study Design:
This is a Phase I, randomized, placebo-controlled, double-blinded study to examine safety, tolerability and immune response of a multiclade HIV adenoviral vector vaccine in uninfected adults. The hypothesis is that this vaccine will be safe and elicit immune responses to HIV. The primary objective is to evaluate the safety and tolerability of VRC-HIVADV014-00-VP in uninfected subjects and the secondary objectives include immunogenicity evaluations and adenovirus serotype 5 (Ad5) antibody titers through Week 4 and social impacts at Week 24. Exploratory evaluations include immunogenicity evaluations at Weeks 12 and 24 and Ad5 antibody titers at Week 24.
Product Description:
VRC-HIVADV014-00-VP is a recombinant product composed of 4 adenoviral vectors (Ad) (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. The final formulation buffer, VRC-DILUENT013-DIL-VP will be used as the diluent and as the placebo control. Injections will be administered intramuscularly (IM).
Subjects:
Healthy adult volunteers (18 to 44 years old).
Study Plan:
Thirty-six volunteers will receive one 1.0 mL injection of the study agent or placebo in a deltoid muscle as shown in the schema. Dose escalation will occur about three weeks after the last injection in a dose group following an interim safety data review by a DSMB, provided that there are no significant toxicities.
Study Duration:
Subjects will be evaluated at 5 or more clinical visits for 24 weeks after the study injection, followed by annual telephone or mail contact for the subsequent 4 years.
Study Endpoints:
The primary endpoint is safety of the vaccine administered at doses of 1 x 10(9), 1 x 10(10) and 1 x 10(11) particle units (PU) by intramuscular injection. Secondary endpoints are immunogenicity as indicated by HIV-specific antibody and cellular immune responses through Week 4, Ad5 antibody titer at Week 0 and Week 4 and social impact at Week 24. Exploratory analyses of immunogenicity at Weeks 12 and 24 and Ad5 antibody titer at Week 24 will also be performed.
- Conditions
- Healthy, HIV Infections
- Being tested
- VRC-HIVADV014-00-VP
- Keywords
- Healthy, T Cells, Immunity, Healthy Volunteer, HV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRC-HIVADV014-00-VPDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2004 (estimated)
- Study start18 May 2004
- Primary completion1 Oct 2009
- Study completion1 Oct 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 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
- 36 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00083330
- Sponsor's protocol ID
- 040172
- Other IDs
- 04-I-0172
- Status last verified
- 1 Oct 2009
- First submitted
- 20 May 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Borrow P, Lewicki H, Hahn BH, Shaw GM, Oldstone MB. Virus-specific CD8+ cytotoxic T-lymphocyte activity associated with control of viremia in primary human immunodeficiency virus type 1 infection. J Virol. 1994 Sep;68(9):6103-10. doi: 10.1128/JVI.68.9.6103-6110.1994.
PubMed 8057491Koup RA, Safrit JT, Cao Y, Andrews CA, McLeod G, Borkowsky W, Farthing C, Ho DD. Temporal association of cellular immune responses with the initial control of viremia in primary human immunodeficiency virus type 1 syndrome. J Virol. 1994 Jul;68(7):4650-5. doi: 10.1128/JVI.68.7.4650-4655.1994.
PubMed 8207839Pantaleo G, Demarest JF, Soudeyns H, Graziosi C, Denis F, Adelsberger JW, Borrow P, Saag MS, Shaw GM, Sekaly RP, et al. Major expansion of CD8+ T cells with a predominant V beta usage during the primary immune response to HIV. Nature. 1994 Aug 11;370(6489):463-7. doi: 10.1038/370463a0.
PubMed 8047166Catanzaro 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
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 Recombinant Multiclade HIV-1 Adenoviral Vector Vaccine, VRC-HIVADV014-00-VP, in Uninfected Adult Volunteers
- ClinicalTrials.gov ID
- NCT00083330
- Acronym / sponsor ID
- 040172
- Conditions
- Healthy, HIV Infections
- Keywords
- Healthy, T Cells, Immunity, Healthy Volunteer, HV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 18 May 2004
- Primary completion
- 1 Oct 2009 (actual)
- Study completion
- 1 Oct 2009 (actual)
- First posted
- 20 May 2004 (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 infection and see if it causes an immune response to HIV. The vaccine is given by injection (shot) in the upper arm. It is made from DNA that codes for three HIV proteins. The DNA is inserted into an adenovirus that carries it into the muscle cells. The adenovirus normally can cause eye or upper respiratory infections, such as a cold; however, for the vaccine, it has been modified so that it cannot cause illness. Nor can the vaccine cause HIV infection, because it codes for only three of the nine HIV proteins.
Healthy, normal volunteers between 18 and 44 years of age who are not HIV-infected may be eligible for this study. Candidates are screened with a medical history and physical examination and blood and urine tests.
Participants are randomly assigned to receive either the experimental vaccine or a placebo (an inactive substance that looks like the vaccine). The vaccine or placebo is administered to participants in groups, according to their entry into the study. The first group receives the lowest study dose of vaccine. If this dose is safe, then the second group receives a higher dose. If this dose is also safe, then the third and final group receives the highest study dose. Clinic staff observe the subjects for side effects for 30 minutes after the injection, and subjects keep a diary card for the next 5 days, recording their temperature and any symptoms that may appear. Subjects are contacted by a nurse 2 days after the injection for follow-up.
Participants are seen at the clinic for follow-up visits 1, 2, 4, 12, and 24 weeks after the injection, and then are contacted by telephone for follow-up once a year until 5 years after the injection. The clinic visits include a physical examination, medical history, blood and urine tests, and HIV counseling, as needed. Women have pregnancy tests at the screening evaluation and again at study week 24. All subjects are tested for HIV at screening and at study weeks 12 and 24, and all subjects complete a "social impact questionnaire" at week 24. All subjects are asked questions about their sexual behavior and drug use.
...
Detailed description
Study Design:
This is a Phase I, randomized, placebo-controlled, double-blinded study to examine safety, tolerability and immune response of a multiclade HIV adenoviral vector vaccine in uninfected adults. The hypothesis is that this vaccine will be safe and elicit immune responses to HIV. The primary objective is to evaluate the safety and tolerability of VRC-HIVADV014-00-VP in uninfected subjects and the secondary objectives include immunogenicity evaluations and adenovirus serotype 5 (Ad5) antibody titers through Week 4 and social impacts at Week 24. Exploratory evaluations include immunogenicity evaluations at Weeks 12 and 24 and Ad5 antibody titers at Week 24.
Product Description:
VRC-HIVADV014-00-VP is a recombinant product composed of 4 adenoviral vectors (Ad) (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. The final formulation buffer, VRC-DILUENT013-DIL-VP will be used as the diluent and as the placebo control. Injections will be administered intramuscularly (IM).
Subjects:
Healthy adult volunteers (18 to 44 years old).
Study Plan:
Thirty-six volunteers will receive one 1.0 mL injection of the study agent or placebo in a deltoid muscle as shown in the schema. Dose escalation will occur about three weeks after the last injection in a dose group following an interim safety data review by a DSMB, provided that there are no significant toxicities.
Study Duration:
Subjects will be evaluated at 5 or more clinical visits for 24 weeks after the study injection, followed by annual telephone or mail contact for the subsequent 4 years.
Study Endpoints:
The primary endpoint is safety of the vaccine administered at doses of 1 x 10(9), 1 x 10(10) and 1 x 10(11) particle units (PU) by intramuscular injection. Secondary endpoints are immunogenicity as indicated by HIV-specific antibody and cellular immune responses through Week 4, Ad5 antibody titer at Week 0 and Week 4 and social impact at Week 24. Exploratory analyses of immunogenicity at Weeks 12 and 24 and Ad5 antibody titer at Week 24 will also be performed.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (36 listed)
- 18 to 44 years old.
- Available for clinical follow-up through Week 24 and telephone or mail contact for an additional 4 years.
- Able to provide proof of identity to the satisfaction 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 complete the informed consent process.
Key exclusion criteria (27 listed)
- A volunteer will be excluded if one or more of the following conditions apply.
- 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
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-HIVADV014-00-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 8057491Borrow P, Lewicki H, Hahn BH, Shaw GM, Oldstone MB. Virus-specific CD8+ cytotoxic T-lymphocyte activity associated with control of viremia in primary human immunodeficiency virus type 1 infection. J Virol. 1994 Sep;68(9):6103-10. doi: 10.1128/JVI.68.9.6103-6110.1994.
- Background: PubMed 8207839Koup RA, Safrit JT, Cao Y, Andrews CA, McLeod G, Borkowsky W, Farthing C, Ho DD. Temporal association of cellular immune responses with the initial control of viremia in primary human immunodeficiency virus type 1 syndrome. J Virol. 1994 Jul;68(7):4650-5. doi: 10.1128/JVI.68.7.4650-4655.1994.
- Background: PubMed 8047166Pantaleo G, Demarest JF, Soudeyns H, Graziosi C, Denis F, Adelsberger JW, Borrow P, Saag MS, Shaw GM, Sekaly RP, et al. Major expansion of CD8+ T cells with a predominant V beta usage during the primary immune response to HIV. Nature. 1994 Aug 11;370(6489):463-7. doi: 10.1038/370463a0.
- Derived from this study: PubMed 17109335Catanzaro 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.
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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 VRC-HIVADV014-00-VP in people with Healthy and 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 36 inclusion and 27 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 NCT00083330, 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; AzTrials last refreshed its copy on 8 Nov 2026.