Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
This is a Phase I, randomized, double-blind, placebo-controlled clinical study to define the safety and immunogenicity resulting from a rapid dose-escalating vaccination schedule as compared to that of a co-administered, dose-consistent vaccination schedule. Participants randomized to receive vaccines will get either dose-consistent injections of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV or rapid, dose-escalating injections of CH505 TF chTrimer+ALFQ with an Ad26.Mos4.HIV prime, followed by dose-consistent injection of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV
Full description
This study is exploratory and will be a randomized, placebo-controlled, double-blind trial. A total of 50 healthy male and female participants, aged 18 to 50 years, who are at low risk for Human Immunodeficiency Virus (HIV) acquisition will be enrolled and randomized across two Arms with 25 individuals per Arm. In each Arm, participants will be randomized 4:1 to active study vaccine versus placebo (normal saline) and followed for up to 18 months. All products will be administered by intramuscular (IM) injection into the same quadriceps muscle at each product administration visit.
Participants randomized to receive active study vaccines in Arm 1 will receive dose-consistent injections of Ad26.Mos4.HIV (5x10^10 viral particles [vp]/0.5 mL) and CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS-21) co-administered on Study Days 1, 57, and 169.
Participants randomized to receive active study vaccines in Arm 2 will receive a lower dose of Ad26.Mos4.HIV (2.5x10^10 vp/0.25 mL) and CH505 TF chTrimer (30 µg)+ALFQ (50 µg MPLA/25 µg QS-21) on Study Day 1, followed by rapid dose-escalating injections of CH505 TF chTrimer (100 µg, 150 µg, and 300 µg)+ALFQ (50 µg MPLA/25 µg QS-21) over a 14-day period, then injections of Ad26.Mos4.HIV (5x10^10 vp/0.5 mL) and CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS-21) on Study Days 57 and 169.
Enrollment into Arms 1 and 2 will be concurrent. Sentinel groups, comprised of the first four participants enrolled in each Arm (3:1 active vaccine to placebo), will be included to facilitate an assessment of the safety of the combination of products and vaccination regimens.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Participants must meet all of the following criteria to be eligible for participation:
Male or female, aged 18 to 50 years, inclusive, at the time of enrollment
Willing and able to read, sign, and date the informed consent form
Demonstrates an understanding of the study with a passing score (90% or greater) on the TOU by the third attempt, before study-related procedures are performed
Willing and able to comply with study requirements and be available to attend visits for the duration of study participation
Must have the means to be contacted by telephone for the duration of study participation
Willing to have photo or fingerprint taken for identification purposes
At low risk for HIV acquisition per investigator assessment
Agrees to refrain from donating blood or plasma outside of this study for at least the duration of study participation
Healthy based on the physician investigator's clinical judgment after review of past medical history, medication use, vital signs, and an abbreviated physical examination
Note: Good health is defined by the absence of any medical condition described in the exclusion criteria in a participant with a normal abbreviated physical exam and vital signs. If the participant has a preexisting chronic condition not listed in the exclusion criteria, the condition cannot meet any of the following criteria:
Note: Vital signs must be normal by Adverse Event Grading Scales, local normal ranges, or determined to be a normal variant by the physician investigator.
Note: An abbreviated physical exam differs from a complete exam in that it does not include a genitourinary and rectal exam.
Laboratory criteria within 45 days prior to enrollment:
Biological Male-Specific Criteria:
Biological Female-Specific Criteria:
Exclusion criteria
Volunteers will be excluded if any of the following apply:
Body mass index (BMI) <18.0 kg/m^2 and >35.1 kg/m^2
Has a condition which affects immune function, including but not limited to:
Has a history of other chronic or clinically significant diseases or medical conditions that in the opinion of the investigator would jeopardize the safety or rights of the participant Note: Includes but is not limited to sickle cell anemia, chronic hepatitis or cirrhosis, chronic urticaria, chronic cardiac disease, hypertension not controlled by medication, severe asthma, chronic pulmonary disease, renal failure, and lymphatic filariasis.
Has a history of malignancy other than squamous cell or basal cell skin cancer, unless there has been definitive surgical and/or medical treatment that is considered to have achieved a cure
Had major surgery (per the physician investigator's judgment) within the 28 days prior to screening or has plans to have major surgery during the study
Has a personal or family history of a bleeding disorder, such as factor deficiency, coagulopathy, or platelet disorder requiring special precautions
Has a personal or family history of a blood clotting disorder, such as thrombosis with thrombocytopenia syndrome (TTS), heparin-induced thrombocytopenia and thrombosis (HITT), deep vein thrombosis, pulmonary embolism, acute myocardial infarction, and stroke
Has a condition known to increase risk of blood clotting, including but not limited to autoimmune disease, connective tissue and other inflammatory conditions, immobility, recent infection, and recent head trauma including cerebrovascular accidents (stroke)
Hepatitis B surface antigen positive at any time in the past
Untreated syphilis infection as confirmed by RPR or a similar quantitative nontreponemal test such as VDRL
Prior receipt or plans to receive any of the following:
Has a known allergy or history of anaphylaxis or other serious reaction to a vaccine, vaccine component, or latex
Current or planned participation in another study requiring blood draws or exposure to investigational or non-investigational vaccine/product (pharmaceutical or device) throughout the study period
Has tattoos, scars, or other marks that would, in the opinion of the physician investigator, interfere with the assessment of the injection sites
Current or history of substance abuse within 12 months prior to enrollment that, in the physician investigator's opinion, could interfere with reliable participation
In the physician investigator's opinion, is unable to communicate reliably, is unlikely to adhere to study requirements, or has a condition that would limit completion of the study
Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the participant or potentially impairs immune response or threatens conduct of the study according to protocol
Study site employee
Final evaluation of eligibility will be based on the medical judgment of the physician investigator.
Primary purpose
Allocation
Interventional model
Masking
50 participants in 2 patient groups
Loading...
Central trial contact
Grace Mirembe, MBChB, MMed; Hannah Kibuuka, MBChB, MMed
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal