Safety, Tolerability and Immunogenicity Study of 2 Dose Levels of Trimeric Glycoprotein140 (gp140) in Healthy Adult Volunteers
3 de junho de 2016 atualizado por: Crucell Holland BV
A First in Human Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Dose Levels of Trimeric gp140 Protein in Healthy Adult Volunteers
The purpose of this study is to assess the safety and tolerability of 2 different dose levels of trimeric glycoprotein140 (gp140) administered as a 2-dosage regimen, intramuscularly (injection of a substance into a muscle), with and without aluminum phosphate as adjuvant in healthy human immunodeficiency virus (HIV)-uninfected participants.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
This is a single-center, randomized (the study drug is assigned by chance), placebo-controlled (study in which the experimental treatment or procedure is compared to a pretend treatment with no drug in it to test if the drug has a real effect), and double-blind (neither physician nor participant knows the treatment that the participant receives) study.
The study comprises a Screening Period (up to 4 weeks), a Vaccination Period (participants will be vaccinated on Days 1 and 29), and a Follow-up Period (up to 48 weeks).
All eligible participants will be randomly assigned to 1 of the 2 sequential cohorts (low dose cohort and high dose cohort).
Participants in low dose cohort will receive 1 of the following treatments: low dose (50 microgram [mcg]) gp140 drug product (DP), low dose gp140 DP with adjuvant (aluminum phosphate), placebo matched to low dose DP; and participants in high dose cohort will receive 1 of the following treatments: high dose (250 mcg) gp140 DP, high dose gp140 DP with adjuvant, and placebo matched to high dose DP.
There will be an interim safety review of safety/tolerability from low-dose cohort before the high-dose cohort receives study treatment.
Total study duration will be 56 weeks per participant.
Participants' safety will be monitored throughout the study.
Tipo de estudo
Intervencional
Inscrição (Real)
50
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Florida
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Miami, Florida, Estados Unidos
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 50 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Participant must be healthy on the basis of physical examination, medical history, electrocardiogram (ECG), laboratory criteria, and vital signs measurement performed at Screening
- Participants are negative for human immunodeficiency virus (HIV) infection at Screening (negative United States Food and Drug Administration-approved HIV diagnostic blood test)
- All female participants of childbearing potential must have a negative serum (beta human chorionic gonadotropin) at Screening, and a negative urine pregnancy test pre-dose on Day 1 and Day 29
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction until 3 months after receiving the last dose of study vaccine. A man must agree not to donate sperm until 3 months after receiving the last dose of study vaccine
- Participants are assessed by the clinic staff as being at low risk for HIV infection
Exclusion Criteria:
- Participant has chronic active hepatitis B or active hepatitis C, active syphilis infection, chlamydia, gonorrhea, or trichomonas. Active syphilis documented by exam or serology unless positive serology is due to past treated infection
- In the 12 months prior to enrollment, participant has a history of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B
- Participant has any clinically significant acute or chronic medical condition that in the opinion of the Investigator would preclude participation (for example, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, poorly controlled asthma, active tuberculosis or other systemic infections)
- Participant has had major surgery within the 4 weeks prior to study entry or planned major surgery through the course of the study
- Participant has had a thyroidectomy, or thyroid disease requiring medication during the last 12 months
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador de Placebo: Placebo 1
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Placebo matched to gp 140 vaccine drug product will be administered intramuscularly on Day 1 and Day 29.
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Comparador de Placebo: Placebo 2
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Placebo matched to gp 140 vaccine drug product will be administered intramuscularly on Day 1 and Day 29.
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Experimental: gp140, 50 mcg
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Glycoprotein 140 (gp140) vaccine containing 50 microgram (mcg) total protein will be administered intramuscularly on Day 1 and Day 29.
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Experimental: gp140, 50 mcg + Adjuvant
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The gp140 vaccine containing 50 mcg total protein mixed with 0.425 milligram (mg) aluminum phosphate adjuvant will be administered intramuscularly on Day 1 and Day 29.
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Experimental: gp140, 250 mcg
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The gp140 vaccine containing 250 mcg total protein will be administered intramuscularly on Day 1 and Day 29.
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Experimental: gp140, 250 mcg + Adjuvant
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The gp140 vaccine containing 250 mcg total protein mixed with 0.425 mg aluminum phosphate adjuvant will be administered intramuscularly on Day 1 and Day 29.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Number of Participants With Local and Systemic Reactogenicity Events Over 8 Days After First Vaccination
Prazo: Day 8
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Participants will be asked to note occurrences of local reactions: erythema, induration, swelling, pain/tenderness, itching, or warmth at the injection site, and systemic events: daily temperature, fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching daily for 8 days post-vaccination.
These occurrences will be recorded through the memory aid provided to serve as a reminder to the participants for the next clinic visit.
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Day 8
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Number of Participants With Local and Systemic Reactogenicity Events Over 8 Days After Second Vaccination
Prazo: Day 36
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Participants will be asked to note occurrences of local reactions: erythema, induration, swelling, pain/tenderness, itching, or warmth at the injection site, and systemic events: daily temperature, fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching daily for 8 days post-vaccination.
These occurrences will be recorded through the memory aid provided to serve as a reminder to the participants for the next clinic visit.
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Day 36
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Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Prazo: Week 52 or early withdrawal
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An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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Week 52 or early withdrawal
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Envelop (Env) Binding Antibody Titer at Week 8
Prazo: Week 8
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The humoral immune response will be assessed by Env Clade C-specific enzyme-linked immunosorbent assay (ELISA) binding antibody titer at Week 8.
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Week 8
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Diretor de estudo: Crucell Holland BV Clinical Trials, Crucell Holland BV
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de dezembro de 2014
Conclusão Primária (Real)
1 de abril de 2016
Conclusão do estudo (Real)
1 de abril de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
26 de novembro de 2014
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de novembro de 2014
Primeira postagem (Estimativa)
1 de dezembro de 2014
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
6 de junho de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de junho de 2016
Última verificação
1 de junho de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- CR104488
- HIV-V-A003 (Outro identificador: Crucell Holland BV)
- IPCAVD008 (Outro identificador: Crucell Holland BV)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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