Iron and Vaccine Response | NCT04912661

Studies
Iron and Vaccine Response

NCT04912661

Sponsor

Swiss Federal Institute of Technology

Status

Completed

Last Update Posted

Sep 14, 2021Actual

Enrollment

121Actual

Phase

Not Applicable

Conditions

Iron Deficiency Anemia
Vaccine Preventable Disease
Vaccine Response Impaired
Iron Deficiency Anemia Treatment

Interventions

Ferinject

Countries

Kenya

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 29, 2021Actual

Primary Completion Date

Sep 9, 2021Actual

Completion Date

Sep 9, 2021Actual

First Submitted Date

May 28, 2021

First Submission Date that Met QC Criteria

May 28, 2021

First Posted Date

Jun 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 10, 2021

Last Update Posted Date

Sep 14, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Nicole Stoffel, PhD, Swiss Federal Institute of TechnologyPrincipal Investigator

Lead Sponsor

Swiss Federal Institute of TechnologyOTHER

Collaborators

Name	Class
Jomo Kenyatta University of Agriculture and Technology	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Vaccines often underperform in Africa compared to high-income countries. Why vaccines do not work as well in Africa remains uncertain. Malnutrition likely plays a role. Our study objective is to assess whether iron deficiency anaemia in young women impairs their immune response to viral vaccines, and whether iron treatment improves their response.

Detailed Description

Group 1 (immediate iron treatment) will receive iron treatment before vaccination. Women in both groups will receive two intramuscular vaccines (influenza and yellow fever). Vaccine response will be measured 28 and 56 days after vaccine administration in both groups. Group 2 (delayed iron treatment) will receive iron treatment at study end.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

121Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immediate iron treatment	Active Comparator	intravenous iron carboxymaltose before vaccination	Dietary Supplement: Ferinject
No iron treatment	No Intervention	no intravenous iron carboxymaltose before vaccination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ferinject	Dietary Supplement	intravenous iron carboxymaltose	Immediate iron treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Antibody titers		at 35 days
Antibody titers		at 63 days
Seroconversion		at 35 days
Seroconversion		at 63 days
Antibody avidity Index	percentage of antibodies that remain bound to beads	at 35 days
Antibody avidity Index	percentage of antibodies that remain bound to beads	at 63 days

Secondary Outcomes

Measure	Description	Time Frame
antiviral immunoglobulin G response	Immunoassay	day 0
antiviral immunoglobulin G response	Immunoassay	day 7

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-55 years old
Zinc protoporphyrin > or equal 40 mmol/mol heme
hemoglobin < or equal 109 g/L
no malaria
no known HIV infection
no medical condition that precludes study involvement
no iron supplementation 1 week prior to study start
no recent tuberculosis infection
no vaccination of yellow fever or influenza prior to enrolment
not pregnant

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicole Stoffel, PhD	ETH Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Msambweni County Referral Hospital		Msambweni	Kwale County		Kenya

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency
D000079263	Vaccine-Preventable Diseases

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C522335	ferric carboxymaltose

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided