RECRUITING

Safety, Tolerability, and Immunogenicity of ALFQ in a HIV Vaccine Containing A244 and B.65321 in Healthy Adults

Conditions

Human Immunodeficiency Virus (HIV)AIDS Virus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the safety and tolerability (including reactogenicity) of candidate vaccine A244/B.63521 with Army Liposome Formulation (ALF) mixed with the saponin QS-21(Quillaja saponaria-21) (ALFQ) adjuvant. The purpose of this phase I randomized, double-blind clinical trial is to optimize vaccine adjuvant ALFQ dosing by assessing safety, reactogenicity, and immunogenicity. Safety and tolerability will be assessed with both clinical and laboratory monitoring. Sixty human immunodeficiency virus (HIV) negative participants will be enrolled to one of three arms. Vaccinations via intramuscular (IM) injection will occur at months 0, 1, and 2. All participants will receive A244 and B.63521 (300 micrograms of each). In addition, Arm 1 will receive 200 micrograms of ALFQ. Arm 2 will receive 100 micrograms of ALFQ. Arm 3 will receive 50 micrograms of ALFQ.

Official Title

A Phase 1 Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of Ranging Doses of ALFQ Adjuvant in a Candidate HIV Vaccine Containing A244 and B.65321

Quick Facts

Study Start:2022-08-29

Study Completion:2028-10-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05423418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. Healthy adults between the ages 18-55 years (inclusive) 2. Must be at low risk for HIV infection per investigator assessment and using the study risk assessment tool. 3. Able and willing to provide written, informed consent 4. Able and willing to comply with all research requirements, in the opinion of the Investigator 5. Agreement to refrain from blood donation during the course of the study 6. Minimum body weight of 110 pounds (lbs) (50kg) 7. Laboratory Criteria within 30 days before enrollment: 1. Hemoglobin ≥ 12.0 g/dL for women; ≥ 12.5 g/dL for men 2. White Blood Cell count = 3,500-10,800 cells/mm3 3. Platelets ≥140,000/mm3 and ≤ 450,000/mm3 4. Alanine aminotransferase (ALT; SGPT) \<1.25 x Upper Limit of Normal (ULN) 5. Serum creatinine ≤ 1.25 x institutional upper limit of the reference range 6. Negative HIV testing (HIV Ab / antigen 4th generation screen with reflex confirmatory RNA testing) 7. Negative HBsAg and hepatitis C antibody testing Note: As above, Grade 1 lab abnormalities detected on screening may be repeated at PI discretion. Persistent Grade 1 abnormalities that are felt to represent the non-pathologic baseline for the subject will be documented before a subject is enrolled in the trial and are allowable per discretion of the PI. 8. Birth control requirements: 1. No reproductive potential due to post-menopausal status (12 months of natural \[spontaneous\] amenorrhea) or hysterectomy, bilateral oophorectomy, or tubal ligation 2. People of childbearing potential should agree to practice highly effective contraception at least 30 days before enrollment and through 3 months post-last vaccination, using one of the following methods: condoms (male or female) with spermicide; diaphragm, or cervical cap with spermicide; intrauterine device; contraceptive pills, patch, injection, intravaginal ring or other FDA-approved contraceptive method; male partner has previously undergone a vasectomy; abstinence 3. All participants are encouraged to engage in safe sex practices to prevent HIV acquisition 9. For all participants assigned female at birth, except those with a history of hysterectomy or bilateral oophorectomy, a negative β-human chorionic gonadotropin (HCG) pregnancy test (urine) on the day of enrollment and each vaccination day is required. Because tubal ligations have a failure rate that is not insignificant, and because 12 months of spontaneous amenorrhea can be a result of polycystic ovarian syndrome and does not completely preclude pregnancy, a negative β- HCG pregnancy test at enrollment and on each vaccination day is also required for participants assigned female at birth with a history of either of these). 10. No plans to travel outside the Washington DC metro area (DC, Maryland, and Virginia) that would prevent compliance with planned study visits 11. Test of Understanding (TOU) (minimum passing score of 80% with 2 attempts permitted)	1. Receipt of any investigational HIV vaccine or investigational adjuvant 2. Received an investigational product in the 30 days before enrollment, or planned to receive during the study period. This does not include products with emergency use authorization. 3. Concurrent participation in another clinical research study 4. Any serious medical illness or condition 5. Receipt of immunoglobulins or blood products within 3 months before enrollment 6. Any history of anaphylaxis or allergy to study product 7. History of sickle cell trait or disease 8. Pregnancy, lactation, or intention to become pregnant during the study 9. History of active/recent cancer still within treatment or active surveillance follow-up (except basal cell carcinoma of the skin and cervical carcinoma in situ). Treated/resolved cancers with no likelihood of recurrence may be deemed acceptable at Principal Investigator (PI) discretion. 10. History of autoimmune disease 11. History of Potentially Immune-Mediated Medical Conditions (PIMMCs) 12. Suspected or known current alcohol or drug abuse as defined by an alcohol intake of greater than 3 drinks a day on average for a man, and greater than 2 drinks a day on average for a woman 13. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to give informed consent, participate in the study, or impair interpretation of the study data, in the opinion of the Investigator 14. History of splenectomy 15. History of confirmed or suspected immunodeficiency 16. History of hereditary angioedema (HAE) acquired angioedema (AAE), or idiopathic forms of angioedema 17. History of asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years 18. History of diabetes mellitus (type I or II), with the exception of gestational diabetes 19. History of thyroid disease (except for well controlled hypothyroidism) 20. History of idiopathic urticaria within the past year 21. History of hypertension that is not well controlled by medication or that is persistently greater than 140/95 at screening 22. History of bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws 23. History of chronic or active neurologic disease to include seizure disorder and chronic migraine headaches. Exceptions are: i) childhood febrile seizures, or ii) seizures secondary to alcohol withdrawal more than 3 years ago 24. Subjects receiving any of the following substances: 1. Systemic immunosuppressive medications or cytotoxic medications within 12 weeks before enrollment \[with the exception of a short course of corticosteroids (≤ 14 days duration or a single injection) for a self-limited condition at least 2 weeks before enrollment; inhaled, intranasal or topical steroids are not considered exclusionary 2. Treatment with known immunomodulators including allergy immunotherapy (other than nonsteroidal anti-inflammatory drugs \[NSAIDs\] or stable maintenance immunotherapy (doses not in the process of being increased), at the discretion of the Protocol Safety Review Team (PSRT)) for any reason 3. Live attenuated vaccines within 30 days before initial study vaccine administration 4. Medically indicated subunit, messenger ribonucleic acid (mRNA), or killed vaccines, e.g., influenza, pneumococcal, vaccines with Quillaja saponaria-21 (QS-21) as an adjuvant, or allergy treatment with antigen injections, planned for administration 14 days before or after study vaccine administration 25. History of arthritis diagnosis other than osteoarthritis 26. History of other diagnosed rheumatoid disorders 27. Has an acute illness or temperature ≥38.0 degrees Celsius (C)/100.4 degrees Fahrenheit (F) on any study injection day or within 48 hours of planned study injection.

Inclusion Criteria

Exclusion Criteria

1. Healthy adults between the ages 18-55 years (inclusive)
2. Must be at low risk for HIV infection per investigator assessment and using the study risk assessment tool.
3. Able and willing to provide written, informed consent
4. Able and willing to comply with all research requirements, in the opinion of the Investigator
5. Agreement to refrain from blood donation during the course of the study
6. Minimum body weight of 110 pounds (lbs) (50kg)
7. Laboratory Criteria within 30 days before enrollment:
1. Hemoglobin ≥ 12.0 g/dL for women; ≥ 12.5 g/dL for men
2. White Blood Cell count = 3,500-10,800 cells/mm3
3. Platelets ≥140,000/mm3 and ≤ 450,000/mm3
4. Alanine aminotransferase (ALT; SGPT) \<1.25 x Upper Limit of Normal (ULN)
5. Serum creatinine ≤ 1.25 x institutional upper limit of the reference range
6. Negative HIV testing (HIV Ab / antigen 4th generation screen with reflex confirmatory RNA testing)
7. Negative HBsAg and hepatitis C antibody testing Note: As above, Grade 1 lab abnormalities detected on screening may be repeated at PI discretion. Persistent Grade 1 abnormalities that are felt to represent the non-pathologic baseline for the subject will be documented before a subject is enrolled in the trial and are allowable per discretion of the PI.
8. Birth control requirements:
1. No reproductive potential due to post-menopausal status (12 months of natural \[spontaneous\] amenorrhea) or hysterectomy, bilateral oophorectomy, or tubal ligation
2. People of childbearing potential should agree to practice highly effective contraception at least 30 days before enrollment and through 3 months post-last vaccination, using one of the following methods: condoms (male or female) with spermicide; diaphragm, or cervical cap with spermicide; intrauterine device; contraceptive pills, patch, injection, intravaginal ring or other FDA-approved contraceptive method; male partner has previously undergone a vasectomy; abstinence
3. All participants are encouraged to engage in safe sex practices to prevent HIV acquisition
9. For all participants assigned female at birth, except those with a history of hysterectomy or bilateral oophorectomy, a negative β-human chorionic gonadotropin (HCG) pregnancy test (urine) on the day of enrollment and each vaccination day is required. Because tubal ligations have a failure rate that is not insignificant, and because 12 months of spontaneous amenorrhea can be a result of polycystic ovarian syndrome and does not completely preclude pregnancy, a negative β- HCG pregnancy test at enrollment and on each vaccination day is also required for participants assigned female at birth with a history of either of these).
10. No plans to travel outside the Washington DC metro area (DC, Maryland, and Virginia) that would prevent compliance with planned study visits
11. Test of Understanding (TOU) (minimum passing score of 80% with 2 attempts permitted)

1. Receipt of any investigational HIV vaccine or investigational adjuvant
2. Received an investigational product in the 30 days before enrollment, or planned to receive during the study period. This does not include products with emergency use authorization.
3. Concurrent participation in another clinical research study
4. Any serious medical illness or condition
5. Receipt of immunoglobulins or blood products within 3 months before enrollment
6. Any history of anaphylaxis or allergy to study product
7. History of sickle cell trait or disease
8. Pregnancy, lactation, or intention to become pregnant during the study
9. History of active/recent cancer still within treatment or active surveillance follow-up (except basal cell carcinoma of the skin and cervical carcinoma in situ). Treated/resolved cancers with no likelihood of recurrence may be deemed acceptable at Principal Investigator (PI) discretion.
10. History of autoimmune disease
11. History of Potentially Immune-Mediated Medical Conditions (PIMMCs)
12. Suspected or known current alcohol or drug abuse as defined by an alcohol intake of greater than 3 drinks a day on average for a man, and greater than 2 drinks a day on average for a woman
13. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to give informed consent, participate in the study, or impair interpretation of the study data, in the opinion of the Investigator
14. History of splenectomy
15. History of confirmed or suspected immunodeficiency
16. History of hereditary angioedema (HAE) acquired angioedema (AAE), or idiopathic forms of angioedema
17. History of asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years
18. History of diabetes mellitus (type I or II), with the exception of gestational diabetes
19. History of thyroid disease (except for well controlled hypothyroidism)
20. History of idiopathic urticaria within the past year
21. History of hypertension that is not well controlled by medication or that is persistently greater than 140/95 at screening
22. History of bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
23. History of chronic or active neurologic disease to include seizure disorder and chronic migraine headaches. Exceptions are: i) childhood febrile seizures, or ii) seizures secondary to alcohol withdrawal more than 3 years ago
24. Subjects receiving any of the following substances:
1. Systemic immunosuppressive medications or cytotoxic medications within 12 weeks before enrollment \[with the exception of a short course of corticosteroids (≤ 14 days duration or a single injection) for a self-limited condition at least 2 weeks before enrollment; inhaled, intranasal or topical steroids are not considered exclusionary
2. Treatment with known immunomodulators including allergy immunotherapy (other than nonsteroidal anti-inflammatory drugs \[NSAIDs\] or stable maintenance immunotherapy (doses not in the process of being increased), at the discretion of the Protocol Safety Review Team (PSRT)) for any reason
3. Live attenuated vaccines within 30 days before initial study vaccine administration
4. Medically indicated subunit, messenger ribonucleic acid (mRNA), or killed vaccines, e.g., influenza, pneumococcal, vaccines with Quillaja saponaria-21 (QS-21) as an adjuvant, or allergy treatment with antigen injections, planned for administration 14 days before or after study vaccine administration
25. History of arthritis diagnosis other than osteoarthritis
26. History of other diagnosed rheumatoid disorders
27. Has an acute illness or temperature ≥38.0 degrees Celsius (C)/100.4 degrees Fahrenheit (F) on any study injection day or within 48 hours of planned study injection.

Contacts and Locations

Study Contact

Paul Adjei, MD

CONTACT

301-500-3799

padjei@hivresearch.org

Principal Investigator

Paul Adjei, MD

PRINCIPAL_INVESTIGATOR

Research Physician at U.S. Military HIV Research Program

Study Locations (Sites)

Walter Reed Army Institute of Research, Clinical Trials Center

Silver Spring, Maryland, 20910

United States

Collaborators and Investigators

Sponsor: U.S. Army Medical Research and Development Command

Paul Adjei, MD, PRINCIPAL_INVESTIGATOR, Research Physician at U.S. Military HIV Research Program

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-29

Study Completion Date2028-10-23

Study Record Updates

Study Start Date2022-08-29

Study Completion Date2028-10-23

Terms related to this study

Additional Relevant MeSH Terms

Human Immunodeficiency Virus (HIV)
AIDS Virus