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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_556 |
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A Study to assess the general safety and tolerability of the administration of a 3-dose prime/boost regimen of the MRKAd5 HIV-1 gag vaccine (V520) in subjects with chronic hepatitis C virus infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRKAd5 HIV-1 gag vaccine 1x10^9 vp/dose | Experimental | Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26. |
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| MRKAd5 HIV-1 gag vaccine 1x10^10 vp/dose | Experimental | Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose. |
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| Placebo | Experimental | Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26. |
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| Open Label Tetanus and Diptheria Toxoids Adsorbed | Sham Comparator | Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRKAd5 HIV-1 gag vaccine (V520) | Biological | 3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10^9 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) | Serious and non serious clinical (systemic and injection-site AEs), and laboratory AEs were collected. Systemic and laboratory AEs reflect any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. Vaccine-related AEs are those determined by the investigator to be possibly, probably, or definitely related to the administration of the vaccine. | up to Week 78 (52 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Systemic and Laboratory Adverse Events (AE) | Adverse experiences collected include serious and non serious systemic AEs, injection-site AEs, and laboratory AEs. Systemic and laboratory AEs include any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose. |
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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 participants had to be at low risk of acquiring human immunodeficiency virus (HIV) infection, and had to meet a number of laboratory criteria. They could not have received treatment for hepatitis C virus infection in the 3 months prior to enrollment and must not anticipate to begin treatment with in 1 year after enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose | Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26. |
| FG001 | MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: Placebo | Biological | 1.0 mL intramuscular injection of Placebo at Day 1 and Weeks 4 and 26 |
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| Comparator: Open Label Tetanus and Diptheria Toxoids Adsorbed | Biological | 0.5 mL Open Label Tetanus and Diptheria Toxoids Adsorbed (Td) intramuscular injection at Day 1 only |
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| MRKAd5 HIV-1 gag vaccine (V520) | Biological | 3-dose prime boosting regimen of 1.0-mL intramuscular injections of 1x10^10 viral particles/dose of MRKAd5 HIV-1 gag vaccine (V520) at Day 1 and Weeks 4 and 26 |
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| up to Week 260 (234 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs |
| Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen | Participants expressing HIV antigens (gag) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs). No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00857311) proved it was not efficacious. | Week 30 (4 weeks after boost injection) |
Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26.
Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose.
| FG002 | Placebo | Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26. |
| FG003 | Open Label Tetanus and Diptheria Toxoids Adsorbed | Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose | Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26. |
| BG001 | MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose | Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose. |
| BG002 | Placebo | Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26. |
| BG003 | Open Label Tetanus and Diptheria Toxoids Adsorbed | Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only. Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group. |
| BG004 | 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, Customized | Mean | Full Range | years |
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| Gender | Number | participants |
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| Region of Enrollment | 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Number of Participants With Systemic and Laboratory Adverse Events (AE) | Adverse experiences collected include serious and non serious systemic AEs, injection-site AEs, and laboratory AEs. Systemic and laboratory AEs include any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. All injection site AEs were collected up to 5 days after any vaccine dose. | Posted | Number | Participants | up to Week 260 (234 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs |
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| Secondary | Immune Response by Levels of Unfractionated Gag-specific IFN-gamma Following a 3-dose Vaccine Regimen | Participants expressing HIV antigens (gag) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag-specific IFN-gamma were to be measured using an Enzyme Linked Immunospot Assay (ELISPOT), which measures spot forming cells per 10^6 peripheral blood mononuclear cells (SFC per million PBMCs). No immunogenicity analyses were performed because the results from a previous study, V520-023 (NCT00095576), which used the same vaccine as the one used in this study (NCT00857311) proved it was not efficacious. | No analysis was performed. | Posted | Week 30 (4 weeks after boost injection) |
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| Primary | Number of Participants With Vaccine-related Clinical (Systemic and Injection-site), and Laboratory Adverse Events (AE) | Serious and non serious clinical (systemic and injection-site AEs), and laboratory AEs were collected. Systemic and laboratory AEs reflect any unfavorable & unintended change in the structure, function, or chemistry of the body. Injection-site AEs include any swelling, redness, pain or tenderness at the injection site. Vaccine-related AEs are those determined by the investigator to be possibly, probably, or definitely related to the administration of the vaccine. | Posted | Number | Participants | up to Week 78 (52 weeks after boost injection) for systemic AEs, 29 days after any dose for laboratory AEs, and 5 days after any dose for injection-site AEs |
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Injection-site AEs up to 5 days after vaccination, non-serious systemic AEs and laboratory AEs up to 29 days after vaccination, serious AEs for the entire study period (Week 260).
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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 Vaccine 1x10^9 vp/Dose | Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26. | 2 | 9 | 9 | 9 | ||
| EG001 | Placebo | Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26. | 2 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatitis C | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Multiple fractures | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
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| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
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| Alcohol abuse | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Eye oedema | Eye disorders | MedDRA (13.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Adverse drug reaction | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Chills | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Feeling hot | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Injection Site Erythema | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Thirst | General disorders | MedDRA (13.0) | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Joint sprain | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
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| Laceration | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
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| Alkaline phosphatase increased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Alcohol abuse | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
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| Dependence | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
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An interim analysis of a related study, V520 Protocol 023 (NCT00095576), showed that the MRKAd5 vaccine used in Protocol 022 (NCT00857311) was not efficacious; therefore, only a high level summary of the safety data was performed.
As this study is part of a multicenter trial, publications derived from this study should include input from the principal investigator, his/her colleagues, the other investigators in this trial, and SPONSOR personnel.
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. SPONSOR review can be expedited to meet publication guidelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Male |
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| With non-serious injection-site AEs |
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| With serious injection-site AEs |
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| With non-serious laboratory AEs |
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| With serious laboratory AEs |
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