The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses

Tetanus Clinical Trial

— Rota-biome  

Official title:

The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538211
• Other study ID #: NL 52510.018.15
• Status: Completed
• Phase: N/A
• First received: August 27, 2015
• Last updated: July 24, 2017
• Start date: September 2015
• Est. completion date: February 2017

Study information

• Verified date: July 2017
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate if the intestinal microbiota influences rotavirus vaccine immune responses in healthy adult volunteers.

Description:

This study will alter the intestinal microbiota in healthy adults using antibiotics and subsequently measure immune reactions to the rotavirus vaccine (Rotarix), the tetanus vaccine and the pneumococcal vaccine (Pneumo23).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: February 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Healthy, as determined by a responsible physician, based on a medical evaluation including medical history, physical examination and laboratory tests carried out within 28 days prior to starting antibiotics (day -98). A subject with a clinical abnormality or laboratory parameter outside the reference range may be included if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures

• Male between 18 and 35 years of age, inclusive at the time of signing the informed consent

• Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form

• Normal defecation pattern (defined as =3x/ day and =3x/week)

Exclusion Criteria:

• Subject has had a major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavorable for enrollment, including inflammatory diseases.

• Subject with any history of immunodeficiency

• Subjects with a history of any type of malignancy

• Subject with a history of thrombocytopenia or bleeding disorder

• Subject has a past or current gastrointestinal disease which may influence the gut microbiota

• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)

• History of alcoholism and/or drinking more than an average of 5 units of alcohol per day

• The subject has received an investigational product within three months of day 0 of the current study

Related Conditions & MeSH terms

• Dysbiosis
• Intestinal Bacteria Flora Disturbance
• Pneumonia
• Pneumonia, Pneumococcal
• Reaction - Vaccine Nos
• Rotavirus Infections
• Streptococcal Pneumonia
• Tetanus

Intervention

Biological:
• Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine
All subjects will be given an oral dose of the rotavirus vaccine, RotarixTM, and intramuscular injections of the Tetanus vaccine and Pneumococcal vaccine, Pneumo 23.

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland

Sponsors (3)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Centers for Disease Control and Prevention, Wageningen University and Research Centre

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height of serum anti-rotavirus Immunoglobulin A (IgA) response	Geometric Mean Concentration (GMC)	28 days post-vaccination
Secondary	Time to positivity for serum anti-rotavirus Immunoglobulin A (IgA) and G (IgG) response	(days)	day 0 through day 28 post vaccination
Secondary	Change in pre and post-vaccination anti-rotavirus (anti-RV) serum neutralizing antibodies measured by Geometric Mean Concentration (GMC)		28 days post-vaccination
Secondary	Change in pre and post-vaccination anti-RV serum IgG response measured by Geometric Mean Concentration (GMC)		day 0 through day 28 post vaccination
Secondary	Change in serum tetanus toxoid IgG response, measured as pre and post vaccination titer (international units/mL) ratio		day 0 through day 28 post vaccination
Secondary	Change in serum pneumococcal poly-saccharide-specific IgG for all vaccine strains , measure in pre and post vaccination titer (micrograms/mL) ratio		day 0 through day 28 post vaccination
Secondary	Composition of the fecal micro biome before and after antibiotics and between groups measured by the HITChip and bacterial 16S rRNA sequencing		day -9 and day 0 pre vaccination