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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_501 |
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This study will test the safety and immunogenicity of an investigational Human Immunodeficiency Virus (HIV) vaccine. Immunogenicity will be measured by evaluating the immune response to several different dose levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose | Experimental | MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. |
|
| MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose | Experimental | MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. |
|
| MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose | Experimental | MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose (V520) | Biological | 3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks | 30 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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All patients had to demonstrate good health, be at low risk of acquiring HIV infection, and met a number of laboratory criteria. They could not have previously received an investigational HIV vaccine, had a contraindication to intramuscular injection, or weighed less than 105 pounds.
Phase IIa; First Patient In: 24-Oct-2006; Last Patient Last Visit 30-May-2008. 21 sites, all in the United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose | MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. |
| FG001 | MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose (V520) | Biological | 3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. |
|
|
| MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose (V520) | Biological | 3-dose regimen of 1.0-mL intramuscular injections of MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. |
|
|
MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
| FG002 | MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose | MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose | MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. |
| BG001 | MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose | MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. |
| BG002 | MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose | MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity | Number | Participants |
| ||||||||||||||||
| Race | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Enzyme-linked Immunosorbent Spot (ELISPOT) Responders at 30 Weeks | No data analysis was performed. | Posted | 30 weeks |
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Non-Serious and Serious AEs were collected for 14 days following each vaccination.
In addition, SAEs that occurred outside the time period specified above were collected if they were either a death or an SAE that was considered possibly, probably, or definitely vaccine related.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose | MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. | 0 | 71 | 56 | 71 | ||
| EG001 | MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose | MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. | 0 | 71 | 63 | 71 | ||
| EG002 | MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose | MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26. | 2 | 68 | 60 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | Systematic Assessment |
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| Haemoglobin decreased | Investigations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pruritus | Eye disorders | Systematic Assessment |
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| Photophobia | Eye disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Chills | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Hangover | General disorders | Systematic Assessment |
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| Influenza like illness | General disorders | Systematic Assessment |
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| Injection site bruising | General disorders | Systematic Assessment |
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| Injection site erythema | General disorders | Systematic Assessment |
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| Injection site movement impairment | General disorders | Systematic Assessment |
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| Injection site pain | General disorders | Systematic Assessment |
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| Injection site pruritus | General disorders | Systematic Assessment |
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| Injection site swelling | General disorders | Systematic Assessment |
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| Malaise | General disorders | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Lethargy | Nervous system disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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An interim analysis of a related study, V520-023 (NCT00095576), showed that the vaccine used in V520-027 (NCT00350623) was not efficacious; therefore, vaccinations in V520-027 were stopped and only a high level summary of safety data was performed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Black or African American |
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| Multi-Racial |
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| Other (Unknown) |
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| White |
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