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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_548 |
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The goal of this study is to understand the safety, tolerability and immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef
Vaccine (MRKAd 5 HIV-1 gag/pol/nef) vaccine in healthy human volunteers compared to placebo. The study will also evaluate a number of dose levels and the necessity for and timing of booster injections.
The study will proceed in four stages. Following stages I, II and III, all subjects will have the Postdose 1 (PD1) clinical and laboratory safety data reviewed by the Safety Evaluation Committee (SEC). If these data are acceptable, the next stage will be initiated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants receiving 1.0 ml of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or the placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26 or a 2-dose regimen at Day 1 and Week 26 or Day 1 and Week 4. |
|
| Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) | Experimental | Participants receiving 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26. |
|
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) | Experimental | Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26. |
|
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) | Experimental | Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine | Other | Placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Experiences | Adverse experiences (AE) collected include serious and non serious systemic AEs, and injection-site 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. | up to 260 weeks after first vaccination |
| Number of Participants With Laboratory Adverse Experiences | Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body. All laboratory AEs were collected up to 29 days after any vaccine dose. | up to 260 weeks after first vaccination |
| Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 3-dose Vaccine Regimen | Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-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). | 4 weeks after booster injection |
| Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 2-dose Vaccine Regimen | Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-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 (NCT00849680) proved it was not efficacious. |
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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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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18433307 | Background | Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, Lalezari J, Santiago S, Marmor M, Lally M, Novak RM, Brown SJ, Kulkarni P, Dubey SA, Kierstead LS, Casimiro DR, Mogg R, DiNubile MJ, Shiver JW, Leavitt RY, Robertson MN, Mehrotra DV, Quirk E; Merck V520-016 Study Group. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis. 2008 Jun 1;46(11):1769-81. doi: 10.1086/587993. | |
| 21695251 |
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317 participants were randomized. 2 did not receive any study medication. Therefore, the safety population was 315.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly. |
| FG001 | Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) | Experimental | Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26. |
|
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) | Experimental | Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26. |
|
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) | Experimental | Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26, or in a 2-dose regimen at Day 1 and Week 4 (with no vaccine administered at Week 26) or Day 1 and Week 26 (with placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine administered at Week 4) |
|
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) | Experimental | Participants receiving 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly in a 3-dose regimen at Day 1, Week 4 and Week 26. |
|
| Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) | Biological | Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) |
|
|
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) | Biological | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) |
|
|
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) | Biological | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) |
|
|
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) | Biological | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) |
|
|
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) | Biological | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) |
|
|
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) | Biological | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) |
|
|
| Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) | Biological | Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) |
|
|
| Comparator: Placebo to MRKAd5 HIV-1 gag vaccine | Biological | Placebo to the MRKAd5 HIV-1 gag vaccine. |
|
| 4 weeks after booster injection |
| Derived |
| Li F, Finnefrock AC, Dubey SA, Korber BT, Szinger J, Cole S, McElrath MJ, Shiver JW, Casimiro DR, Corey L, Self SG. Mapping HIV-1 vaccine induced T-cell responses: bias towards less-conserved regions and potential impact on vaccine efficacy in the Step study. PLoS One. 2011;6(6):e20479. doi: 10.1371/journal.pone.0020479. Epub 2011 Jun 10. |
| 21203546 | Derived | Hutnick NA, Carnathan DG, Dubey SA, Cox KS, Kierstead L, Makadonas G, Ratcliffe SJ, Lasaro MO, Robertson MN, Casimiro DR, Ertl HC, Betts MR. Vaccination with Ad5 vectors expands Ad5-specific CD8 T cells without altering memory phenotype or functionality. PLoS One. 2010 Dec 22;5(12):e14385. doi: 10.1371/journal.pone.0014385. |
3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
| FG002 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly. |
| FG003 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly. |
| FG004 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly. |
| FG005 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly. |
| FG006 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose) | 2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly. |
| FG007 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly. |
| BG001 | Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose) | 3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly. |
| BG002 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly. |
| BG003 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly. |
| BG004 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly. |
| BG005 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly. |
| BG006 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose) | 2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly. |
| BG007 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Full Range | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 Participants With Adverse Experiences | Adverse experiences (AE) collected include serious and non serious systemic AEs, and injection-site 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 260 weeks after first vaccination |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Laboratory Adverse Experiences | Laboratory AEs were based on a grading system considering the severity of abnormal laboratory values in participants and reflect any unfavorable and unintentional change in function, or chemistry of the body. All laboratory AEs were collected up to 29 days after any vaccine dose. | Participants administered at least one dose of study vaccine. One participant who was lost to follow-up, and another one participant who discontinued as he comply with the protocol are not included. | Posted | Number | Participants | up to 260 weeks after first vaccination |
| |||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 3-dose Vaccine Regimen | Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-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 (NCT00849680) proved it was not efficacious. | Posted | 4 weeks after booster injection |
| |||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Immune Response by Levels of Unfractionated Gag, Pol, and Nef-specific IFN-gamma Following a 2-dose Vaccine Regimen | Participants expressing HIV antigens (gag, pol and nef) secrete antigen specific interferon-gamma (IFN-gamma). Levels of unfractionated gag, pol, and nef-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 (NCT00849680) proved it was not efficacious. | 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 (NCT00849680) proved it was not efficacious. | Posted | 4 weeks after booster injection |
|
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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 | Placebo | 1 | 26 | 24 | 26 | |||
| EG001 | Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10[9] vp/Dose) | 2 | 13 | 13 | 13 | |||
| EG002 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[6] vp/Dose) | 2 | 41 | 35 | 41 | |||
| EG003 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[7] vp/Dose) | 3 | 42 | 38 | 42 | |||
| EG004 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[8] vp/Dose) | 4 | 42 | 35 | 42 | |||
| EG005 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[9] vp/Dose) | 3 | 42 | 39 | 42 | |||
| EG006 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[10] vp/Dose) | 7 | 78 | 74 | 78 | |||
| EG007 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10[11] vp/Dose) | 1 | 31 | 31 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery disease | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| Electrocardiogram change | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Ear discomfort | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Feeling of body temperature change | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Bacteria urine identified | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Blood amylase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Haematocrit decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Lymphocyte count increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Red blood cells urine positive | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Urinary sediment present | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| White blood cells urine positive | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
|
An interim analysis of a related study, V520 Protocol 023 (NCT00095576), showed that the MRKAd5 vaccine used in Protocol 016 (NCT00849680) 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 Corp. | clinicaltrialsdisclosure@merck.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
Not provided
Not provided
| Male |
|
| With Injection site AEs |
|
| With serious systemic AEs |
|
| With serious injection site AEs |
|
| OG003 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly. |
| OG004 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly. |
| OG005 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly. |
| OG006 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose) | 2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly. |
| OG007 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly. |
|
|
| OG003 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly. |
| OG004 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly. |
| OG005 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly. |
| OG006 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose) | 2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly. |
| OG007 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly. |
|
3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly. |
| OG003 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly. |
| OG004 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly. |
| OG005 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly. |
| OG006 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose) | 2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly. |
| OG007 | Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose) | 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly. |
|