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Virus Therapy

Ad26.Mos.HIV for Healthy Subjects

Phase 1 & 2
Waitlist Available
Research Sponsored by Janssen Vaccines & Prevention B.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up serious adverse events (saes) were reported up to week 336 for group 1 and 2 and up to week 96 for the other groups (group 3, 4, 5, 6, 7, and 8). other adverse events (aes) were reported for the main study period up to week 96 for all the groups
Awards & highlights

Study Summary

This trial will compare the safety and effectiveness of different vaccine regimens for HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~serious adverse events (saes) were reported up to week 336 for group 1 and 2 and up to week 96 for the other groups (group 3, 4, 5, 6, 7, and 8). other adverse events (aes) were reported for the main study period up to week 96 for all the groups
This trial's timeline: 3 weeks for screening, Varies for treatment, and serious adverse events (saes) were reported up to week 336 for group 1 and 2 and up to week 96 for the other groups (group 3, 4, 5, 6, 7, and 8). other adverse events (aes) were reported for the main study period up to week 96 for all the groups for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Serious Adverse Events (SAEs) Post Vaccination
Percentage of Participants With Solicited Local Adverse Events (AEs) Post Vaccination
Percentage of Participants With Solicited Systemic Adverse Events (AEs) Post Vaccination
+2 more
Secondary outcome measures
Percentage of Responders With Interferon-gamma (IFN-gamma) T Cell Responses Enzyme-linked Immunospot Assay (ELISpot)
Percentage of Responders for Binding Antibody Multiplex Assay (BAMA) IgG1-IgG4 and IgA and IgG-t Breadth Antibody
Percentage of Responders for Clade C (C97ZA.012) Env Enzyme-linked Immunosorbent Assay (ELISA) Immunoglobulin G1 (IgG1), IgG2, IgG3 and IgG4 Glycoprotein (gp) 140 Binding Antibody
+3 more

Side effects data

From 2022 Phase 1 & 2 trial • 393 Patients • NCT02315703
69%
Injection site pain
18%
Injection site pruritus
16%
Injection site erythema
16%
Injection site warmth
14%
Injection site induration
10%
Procedural headache
10%
Urinary tract infection
10%
Influenza
10%
Urinary Tract Infection
10%
Headache
10%
Injection site swelling
8%
Aspartate aminotransferase increased
8%
Aspartate Aminotransferase Increased
8%
Haemoglobin Decreased
8%
Haemoglobin decreased
6%
Malaria
6%
Back Pain
6%
Dizziness postural
6%
Viral infection
6%
Back pain
6%
Neutropenia
6%
Viral Infection
6%
Electrocardiogram QT Prolonged
6%
Dizziness Postural
6%
Electrocardiogram QT prolonged
4%
Upper Respiratory Tract Infection
4%
Dyspepsia
4%
Dysmenorrhoea
4%
Haematuria
4%
Upper respiratory tract infection
4%
Body temperature increased
4%
Alanine aminotransferase increased
4%
Feeling hot
4%
Injection site bruising
4%
Chlamydial infection
4%
Neutrophil count decreased
4%
Procedural nausea
4%
Enteritis
4%
Abdominal Pain Upper
4%
Haemorrhoids
4%
Injection Site Bruising
4%
Pyrexia
4%
Chlamydial Infection
4%
Rhinitis
4%
Alanine Aminotransferase Increased
4%
Neutrophil Count Decreased
4%
Proteinuria
4%
Menorrhagia
4%
Abdominal pain upper
4%
Diarrhoea
4%
Procedural vomiting
4%
Pruritus generalised
2%
Peptic Ulcer
2%
Bacteraemia
2%
Trichomoniasis
2%
Ear Infection
2%
Injection Site Pain
2%
Contusion
2%
Red Blood Cells Urine
2%
Stress Fracture
2%
Eye Pain
2%
Dry Mouth
2%
Body Tinea
2%
Post Procedural Haematoma
2%
Muscle Contusion
2%
Neck pain
2%
Adverse Drug Reaction
2%
Musculoskeletal chest pain
2%
Peptic ulcer
2%
Viral upper respiratory tract infection
2%
Rash pustular
2%
Lumbar vertebral fracture
2%
Bacterial vaginosis
2%
Candida infection
2%
Gun shot wound
2%
Muscle contusion
2%
Post procedural haematoma
2%
Vulvovaginitis trichomonal
2%
Sinus congestion
2%
Skin abrasion
2%
Skin Abrasion
2%
Decreased Appetite
2%
Ear infection
2%
Abortion spontaneous
2%
Eye irritation
2%
Eye pain
2%
Dry mouth
2%
Feeling cold
2%
Peripheral swelling
2%
Body tinea
2%
Pharyngitis streptococcal
2%
Typhoid fever
2%
Vulvovaginal mycotic infection
2%
Red blood cells urine
2%
Decreased appetite
2%
Musculoskeletal pain
2%
Dermatitis atopic
2%
Dermatitis contact
2%
Infusion site pain
2%
Vaccination site joint discomfort
2%
Abortion Spontaneous
2%
Paraesthesia
2%
Abdominal Pain
2%
Tonsillitis
2%
Pyelonephritis
2%
Lumbar Vertebral Fracture
2%
Lymphadenopathy
2%
Ear Pain
2%
Eye Irritation
2%
Food Poisoning
2%
Gastritis
2%
Feeling Cold
2%
Feeling Hot
2%
Peripheral Swelling
2%
Hypersensitivity
2%
Amoebiasis
2%
Bacterial Vaginosis
2%
Candida Infection
2%
Pharyngitis Streptococcal
2%
Rash Pustular
2%
Typhoid Fever
2%
Viral Upper Respiratory Tract Infection
2%
Vulvovaginal Mycotic Infection
2%
Vulvovaginitis Trichomonal
2%
Gun Shot Wound
2%
Procedural Headache
2%
Muscular Weakness
2%
Musculoskeletal Chest Pain
2%
Musculoskeletal Pain
2%
Neck Pain
2%
Presyncope
2%
Syncope
2%
Depression
2%
Sinus Congestion
2%
Dermatitis Atopic
2%
Dermatitis Contact
2%
Pruritus
2%
Urticaria
2%
Hypertension
2%
Hypotension
2%
Abdominal pain
2%
Food poisoning
2%
Adverse drug reaction
2%
Pyuria
2%
Ear pain
2%
Stress fracture
2%
Muscular weakness
2%
Migraine
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 3: Ad26/Ad26
Group 5: Ad26/ MVA + gp140 LD
Group 4: Ad26/MVA + gp140 HD
Group 6: Ad26/MVA
Group 8: Placebo/ Placebo
Group 1: Ad26/Ad26 + gp140 High Dose (HD)
Group 7: Ad26/ gp140 HD
Group 2: Ad26/Ad26 + gp140 Low Dose (LD)

Trial Design

8Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 7Experimental Treatment3 Interventions
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by gp140 DP vaccine containing 250 mcg of total protein mixed with adjuvant + placebo injection at Week 24 and 48.
Group II: Group 6Experimental Treatment3 Interventions
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by MVA-Mosaic vaccine + placebo injection at Week 24 and 48.
Group III: Group 5Experimental Treatment3 Interventions
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by MVA-Mosaic vaccine + gp140 DP vaccine containing 50 mcg of total protein mixed with adjuvant at Week 24 and 48.
Group IV: Group 4Experimental Treatment3 Interventions
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by modified Vaccinia Ankara (MVA)-Mosaic vaccine + gp140 DP vaccine containing 250 mcg of total protein mixed with adjuvant at Week 24 and 48.
Group V: Group 3Experimental Treatment2 Interventions
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + placebo injection at Week 24 and 48.
Group VI: Group 2Experimental Treatment2 Interventions
Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + gp140 DP vaccine containing 50 mcg of total protein mixed with adjuvant at Week 24 and 48.
Group VII: Group 1Experimental Treatment2 Interventions
Participants will receive adenovirus serotype 26-Mosaic -Human Immunodeficiency Virus (Ad26.Mos.HIV) vaccine at Week 0 and 12; followed by Ad26.Mos.HIV vaccine + HIV type 1 Clade C glycoprotein 140 drug product (gp140 DP) vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminum phosphate) at Week 24 and 48.
Group VIII: Group 8Placebo Group1 Intervention
Participants will receive 1 placebo injection at Week 0 and 12; followed by 2 placebo injections at Week 24 and 48.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MVA-Mosaic
2014
Completed Phase 2
~450
gp140 DP Low-dose
2014
Completed Phase 2
~400
Placebo
1995
Completed Phase 3
~2670
gp140 DP High-dose
2014
Completed Phase 2
~400
Ad26.Mos.HIV
2016
Completed Phase 2
~660

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterOTHER
837 Previous Clinical Trials
13,009,879 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,269 Previous Clinical Trials
5,481,076 Total Patients Enrolled
Janssen Vaccines & Prevention B.V.Lead Sponsor
55 Previous Clinical Trials
1,133,955 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention
2014. "Safety, Tolerability, and Immunogenicity Study of Homologous Ad26 Mosaic Vector Vaccine Regimens or Heterologous Ad26 Mosaic and MVA Mosaic Vector Vaccine Regimens With Glycoprotein 140 (gp140) for Human Immunodeficiency Virus (HIV) Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02315703.
~38 spots leftby Apr 2025
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