Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19 · Vaccination · Healthy Volunteer
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- Aceptados
- Participantes
- 103 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
Background:
Vaccines against SARS-CoV-2, the virus that causes COVID-19, have been highly effective against preventing severe disease. But the protective effects of these vaccines appear to wane over time. Researchers want to learn why.
Objective:
To learn more about how the immune system responds to vaccines against infections like SARS-CoV-2.
Eligibility:
Healthy adults ages 18 or older who are scheduled to receive either a new vaccine or a booster shot against SARS-COV-2 or another emerging infection.
Design:
Participants will be screened with a medical history and blood and urine tests.
Participants will have up to 8 study visits in 1 year. Each visit should last less than 2 hours. At each visit, participants will give blood samples. Some blood samples will be used for genetic testing. They will also give updates on their health.
After the first study visit, participants will receive either a first vaccination or a booster shot. They must get the vaccine in their community or workplace. They will not get the vaccine at NIH.
This study currently focuses on SARS-CoV-2, but it will expand to other infectious diseases as they emerge and become the target of new vaccines.
Leer la descripción completa
Study Description: This protocol will enroll up to 200 adults per year who are scheduled to be vaccinated against severe acute respiratory syndromecorona virus 2 (SARS-CoV-2) or other emerging pathogens. Participants will provide blood samples prior to and serially aftervaccination. The blood will be used to perform research studies of the immune response to primary (new) and secondary (booster) vaccines.
Objectives:
Primary Objective: Characterize longitudinal serologic and cellular responses to vaccination to SARS-CoV-2 and other emerging infections.
Secondary Objectives:
1. Evaluate baseline correlates of immune response to vaccination.
2. Correlate cellular and serologic responses after vaccination.
3. For vaccines that require two or more doses; characterize the immunologic responses following both the primary (new) and the secondary (booster) dose(s).
4. Evaluate the longevity of immune responses to primary (new) and secondary (booster) vaccination.
Endpoints: Primary Endpoint: Establish immunologically well characterized cohorts of primary (new) and secondary (booster) vaccinated individuals.
Secondary Endpoints: Establish factors associated with longevity of serologic and cellular responses to primary (new) and secondary (booster) vaccination.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
- INCLUSION CRITERIA:
General Inclusion Criteria for All Groups:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Stated willingness to comply with all study procedures and availability for the duration of the study
2. Age 18 years or older
3. Hemoglobin \>= 9.0 grams per deciliter (g/dL) or \>= 11.2 for women who are pregnant.
4. Willingness to give consent for the storage of blood samples for research
5. Ability of subject to understand and the willingness to sign a written informed consent document
Inclusion Criteria for Primary (New) Vaccination Group:
1\. No history of having received a dose of the vaccine for the infectious disease being studied. Subjects who have enrolled under another Laboratory of Immunoregulation (LIR) protocol and had samples drawn prior to vaccination will also be eligible for enrollment.
Inclusion Criteria for Secondary (Booster) Vaccination Group:
1\. Willingness to return for baseline research blood collection prior to booster vaccination.
EXCLUSION CRITERIA:
1. Current abuse of alcohol or other drugs that, in the judgement of the Principal Investigator (PI) could interfere with patient compliance.
2. Any medical or mental health condition that, in the judgement of the PI, would make the volunteer unable to participate in the study.
Población del estudio
Individuals greater than 18 years of age who are scheduled to receive a initial or booster vaccination to an emerging infectious disease.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
Individuals Receiving Vaccine
Individuals receiving a vaccination for an emerging infection, like SARS-CoV-2
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Characterize longitudinal serologic and cellular responses to vaccination to SARS-CoV-2 and other emerging infections.
Plazo: throughout
Establish immunologically well characterized cohorts of primary and secondary vaccinated individuals.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
1 centros
National Institutes of Health Clinical CenterBethesda, Maryland, United StatesEstado desconocido
Equipo y fechas
- Patrocinador principal
- National Institute of Allergy and Infectious Diseases (NIAID)
- Inicio del estudio
- 13 oct 2021 Real
- Finalización primaria
- 1 ene 2050 Estimado
- Finalización del estudio
- 1 ene 2050 Estimado
- Primera publicación
- 15 oct 2021 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Longitudinal Observations of Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026
