CLINICAL TRIALS PROFILE FOR ADENOVIRUS TYPE 4 AND TYPE 7 VACCINE, LIVE
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All Clinical Trials for adenovirus type 4 and type 7 vaccine, live
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00049218 ↗ | Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer | Completed | H. Lee Moffitt Cancer Center and Research Institute | Phase 1/Phase 2 | 2003-04-01 | RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Combining vaccine therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by adenovirus p53 vaccine therapy in treating patients who have extensive-stage small cell lung cancer. |
| NCT00083330 ↗ | Safety and Immunogenicity of an HIV Vaccine in Normal Adult Volunteers | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 | 2004-05-18 | 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. ... |
| NCT00095576 ↗ | Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023) | Terminated | HIV Vaccine Trials Network | Phase 2 | 2004-11-01 | This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected. On September 18, 2007 the Protocol V520-023 DSMB (Data & Safety Monitoring Board) reviewed data from a planned interim analysis. These data demonstrated that the investigational vaccine candidate was not effective, and all vaccinations in the study were halted. Participants were encouraged to continue to come to the clinic for scheduled visits and ongoing risk reduction counseling since the vaccine was not effective. |
| NCT00095576 ↗ | Investigation of V520 in an HIV Vaccine Proof-of-Concept Study (V520-023) | Terminated | Merck Sharp & Dohme Corp. | Phase 2 | 2004-11-01 | This study will test the safety and efficacy of an investigational Human Immunodeficiency Virus (HIV) vaccine. Efficacy will be measured by either prevention of HIV infection or control of HIV viral load in subjects who become HIV infected. On September 18, 2007 the Protocol V520-023 DSMB (Data & Safety Monitoring Board) reviewed data from a planned interim analysis. These data demonstrated that the investigational vaccine candidate was not effective, and all vaccinations in the study were halted. Participants were encouraged to continue to come to the clinic for scheduled visits and ongoing risk reduction counseling since the vaccine was not effective. |
| NCT00102089 ↗ | HIV-1 Vaccine Booster in Previously Immunized Uninfected Adult Volunteers | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 | 2005-01-18 | This study will test the safety and side effects of an experimental vaccine booster against HIV. A vaccine is a substance given to try to create immunity or resistance to a disease or infection. The vaccine used in this study is called VRC-HIVADV014-00-VP. It is made from an adenovirus (a common virus that causes upper respiratory infections) that contains DNA (genetic material) of three HIV proteins. Injected into a human, the viral DNA instructs the body to make small amounts of some HIV proteins. VRC-HIVADV014-00-VP will be given to people who previously received a vaccine called VRC-HIVDNA009-00-VP under NIH protocol 03-I-0022. Important: Study participants cannot catch an adenovirus infection or HIV or AIDS from the vaccine or any proteins made from it. Healthy normal volunteers who participated in NIH protocol 03-I-0022 may be eligible for this study. They must have completed three injections of 4 mg or 8 mg of VRC-HIVDNA009-00-VP without experiencing a serious side effect that was possibly related to the vaccine. Candidates are screened with a medical history, clinical evaluation, blood and urine tests, and HIV and pregnancy counseling. Participants receive one injection of VRC-HIVADV014-00-VP the day they enroll in the study (study day 0). They are observed for at least 30 minutes after immunization. At home, they record their temperature and any symptoms they may experience, including any effects at the injection site, for 5 days and call a study nurse 1 or 2 days after the injection. They immediately report any symptoms to the clinic staff and, if necessary, come to the clinic for an examination. Participants have five additional clinic visits during the study, at weeks 2, 4, 6, 12 and 24, each lasting about 2 hours. At each visit, they are checked for health changes or problems and are asked about medications they are taking. Blood is drawn for immune function testing, HLA typing (a genetic test of immune system markers), and other genetic factors. A urine sample is collected at some visits. Additional laboratory tests may be requested between visits. Some participants may undergo apheresis at the week 4 visit to collect a large number of white blood cells for laboratory tests to see how the immune system responds to the study vaccine. For this procedure, blood is collected through a needle in an arm vein and flows through a catheter (plastic tube) into a machine that separates it into its components by centrifugation (spinning). The white cells are extracted and the rest of the blood is returned through another needle in the other arm. The procedure takes about 1 to 3 hours. Participants are tested three or more times for HIV and are questioned about their sexual behavior and drug use. They complete a "social impact" questionnaire at week 24 that includes questions about any problems they may have experienced from their participation in the study regarding such things as insurance, health care, friends, family, employment, housing, education, or government agencies. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for adenovirus type 4 and type 7 vaccine, live
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Clinical Trial Locations for adenovirus type 4 and type 7 vaccine, live
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Clinical Trial Progress for adenovirus type 4 and type 7 vaccine, live
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Clinical Trial Sponsors for adenovirus type 4 and type 7 vaccine, live
Sponsor Name
| Sponsor Name for adenovirus type 4 and type 7 vaccine, live | |
| Sponsor | Trials |
| National Institute of Allergy and Infectious Diseases (NIAID) | 13 |
| University of Oxford | 4 |
| National Cancer Institute (NCI) | 4 |
| [disabled in preview] | 7 |
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