Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Ad26.Mos4.HIV and CH505 TF chTrimer (Env) Combination to Mimic Acute HIV Viral Replication Kinetics in Healthy Adults

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

Start Date30 Jan 2024

Sponsor / Collaborator

U S Army Medical Research & Development Command

[+6]

NCT04915768

/ Active, not recruitingPhase 1IIT

A First-in-human Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants.

This is an open-label Phase 1 study to examine the safety and immunogenicity of the CH505 TF chTrimer vaccine with 3M-052-AF +/- Alum adjuvant in healthy adults. The primary hypothesis is that the CH505 TF chTrimer will expand CH103-like B-cell precursors.
HVTN 300 Part A examines the safety and immunogenicity of the CH505TF chTrimer with 5 mcg 3M-052-AF + 500 mcg Alum.
HVTN 300 Part B is being added to this protocol with a goal of assessing the optimal dosing and combination of 3M-052-AF and Alum adjuvant, that can potentially lead to improved neutralizing antibody activity and decreased reactogenicity, compared to Part A. Three groups have been added to Part B (Group 2: 3 mcg 3M-052-AF without Alum, Group 3: 3 mcg 3M-052 with Alum, and Group 4: 5 mcg 3M-052-AF without Alum).

Start Date23 Jan 2023

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

NCT03220724

/ CompletedPhase 1IIT

A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-Uninfected Adult Participants

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs adjuvanted with GLA-SE in healthy, HIV-uninfected adults.

Start Date22 Aug 2017

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with CH505TF(NIAID)

100 Translational Medicine associated with CH505TF(NIAID)

100 Patents (Medical) associated with CH505TF(NIAID)

Literatures (Medical) associated with CH505TF(NIAID)

Journal of Clinical Investigation

Safety and implementation of phase 1 randomized GLA-SE-adjuvanted CH505TF gp120 HIV vaccine trial in newborns

Article

Author: Martin, Troy M ; Angelidou, Asimenia ; Josipovic, Deirdre ; Sagawa, Zachary K ; Violari, Avy ; Hahn, William ; Corey, Lawrence ; Levy, Ofer ; Yen, Catherine ; Baba, Vuyelwa ; Kublin, James G ; Polakowski, Laura ; Haynes, Barton F ; Tomaras, Georgia ; Gray, Glenda E ; Williams, Wilton B ; Mkhize, Nonhlanhla N ; Brewinski Isaacs, Margaret ; Woodward Davis, Amanda S ; Chen, Shiyu ; Otwombe, Kennedy ; Janes, Holly ; Smolen, Kinga K

BACKGROUNDThe neonatal immune system is uniquely poised to generate broadly neutralizing antibodies (bnAbs) and thus infants are ideal for evaluating HIV vaccine candidates. We present the design and safety of a new-in-infants glucopyranosyl lipid A (GLA)-stable emulsion (SE) adjuvant admixed with a first-in-infant CH505 transmitter-founder (CH505TF) gp120 immunogen designed to induce precursors for bnAbs against HIV.METHODSHVTN 135 is a phase I randomized, placebo-controlled trial of CH505TF+GLA-SE or placebo. Healthy infants aged ≤ 5 days, born to mothers living with HIV but HIV nucleic acid negative at birth were randomized to five doses of CH505TF + GLA-SE or placebo at birth and 8, 16, 32, and 54 weeks.RESULTS38 infants (median age = 4 days; interquartile range 4, 4.75 days) were enrolled November 2020 to January 2022. Among 28 (10) infants assigned to receive CH505TF + GLA-SE (placebo), most (32/38) completed the 5-dose immunization series and follow-up (35/38). Solicited local and systemic reactions were more frequent in vaccine (8, 28.6% local; 16, 57.1% systemic) vs. placebo recipients (1, 10% local, P = 0.25; 4, 40.0% systemic, P = 0.38). All events were Grade 1 except two Grade 2 events (pain, lethargy). Serious vaccine-related adverse events were not recorded.CONCLUSIONSThis study illustrates the feasibility of conducting trials of new-in-infants adjuvanted HIV vaccines in HIV-exposed infants receiving standard infant vaccinations. The safety profile of the CH505TF + GLA-SE vaccine was reassuring.TRIAL REGISTRATIONCLINICALTRIALSgov NCT04607408.FUNDINGThe trial was funded through National Institute of Allergy and Infectious Disease of the National Institutes of Health under grants UM1 AI068614 (HVTN Leadership and Operations Center), UM1 AI068635 (HVTN Statistical and Data Management Center), and UM1 AI068618 (HVTN Laboratory Center).

Safety and implementation of a phase 1 randomized GLA-SE-adjuvanted CH505TF gp120 HIV vaccine trial in newborns

Article

Author: Chen, Shiyu ; Yen, Catherine ; Kublin, James ; Smolen, Kinga K ; Josipovic, Deirdre ; Violari, Avy ; Levy, Ofer ; Angelidou, Asimenia ; Sagawa, Zachary K. ; Haynes, Bart ; Mkhize, Nonhlanhla N ; Corey, Lawrence ; Woodward, Amanda S ; Brewinski Isaacs, Margaret ; Baba, Vuyelwa ; Polakowski, Laura ; Williams, Wilton B ; Janes, Holly ; Tomaras, Georgia ; Hahn, William ; Isaacs, Margaret Brewinski ; Sagawa, Zachary K ; Martin, Troy M. ; Gray, Glenda ; Smolen, Kinga K. ; Martin, Troy M ; Williams, Wilton B. ; Otwombe, Kennedy

AbstractBackgroundThe neonatal immune system is uniquely poised to generate broadly neutralizing antibodies (bnAbs) and thus infants are ideal for evaluating HIV vaccine candidates. We present the design and safety of a novel glucopyranosyl lipid A (GLA)-stable emulsion (SE) adjuvant admixed with a first-in-infant CH505 transmitter-founder (CH505TF) gp120 immunogen designed to induce precursors for bnAbs against HIV.MethodsHVTN 135 is a phase I randomized, placebo-controlled trial of CH505TF+GLA-SE or placebo. Healthy infants in South Africa aged ≤5 days, born to mothers living with HIV but HIV nucleic acid negative at birth were randomized to five doses of CH505TF + GLA-SE or placebo at birth and 8, 16, 32, and 54 weeks.Results38 infants (median age = 4 days; interquartile range 4, 4.75 days) were enrolled November 2020 to January 2022. Among 28 (10) infants assigned to receive CH505TF + GLA-SE (placebo), most (32/38) completed the 5-dose immunization series and follow-up (35/38). Solicited local and systemic reactions were more frequent in vaccine (8, 28.6% local; 16, 57.1% systemic) vs. placebo recipients (1, 10% local, p = 0.25; 4, 40.0% systemic, p = 0.38). All events were Grade 1 except two Grade 2 events (pain, lethargy). Serious vaccine-related adverse events were not recorded.ConclusionsThis study illustrates the feasibility of conducting trials of novel adjuvanted HIV vaccines in HIV-exposed infants receiving standard infant vaccinations. The safety profile of the CH505TF + GLA-SE vaccine was reassuring.Trial registration

ClinicalTrials.gov

NCT04607408

FundingNational Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH)Brief summaryThis paper summarizes the phase 1 trial design and safety profile of an experimental CH505TF immunogen + GLA-SE HIV vaccine in infants born to mothers living with HIV.

100 Deals associated with CH505TF(NIAID)

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Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 1	United States	National Institute of Allergy & Infectious Diseases	22 Aug 2017

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