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Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity

Award Number: U19AI118608
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/27/2016
PERIOD OF PERFORMANCE END DATE: 11/30/2023

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Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity - PROJECT SUMMARY Improvement of early life immunization requires a better understanding of vaccine-induced molecular pathways that underlie protective immunogenicity as Correlates of Protection (CoP). Systems vaccinology employing technologies that measure molecular changes (“OMICs”) has provided critical insights into the adult immune response to vaccination, but has yet to be applied to the youngest, despite their need for improved immunization. We will apply powerful OMIC tools to the neonatal immune response to Hepatitis B vaccination (HBV). HBV is an ideal model to define mechanisms of successful neonatal immunization because: a) HBV is highly effective (>90% protection) and has a well-characterized CoP (anti-hepatitis B surface antigen antibody (anti-HBs)); b) anti-HBs titres directly correlate with protection, i.e. the higher anti- HBs the better and more durable protection; c) anti-HBs titers after the fist (neonatal) dose correlate with titers after the last; d) anti-HBs levels vary widely between subjects; such inter-subject variability enables powerful systems vaccinology tools to extract meaningful correlations; e) the neonatal HBV response is sensitive to co-administration of Bacille Calmette-Guérin (BCG), which is routinely given together with HBV in the Expanded Program of Immunization (EPI); this offers the unique opportunity to characterize this in vivo perturbation via OMICs. Our chosen clinical study sites in the Gambia and Papua New Guinea are amongst the world's most experienced with respect to neonatal vaccinology. Here, newborns will be immunized with nothing (delayed), HBV, BCG or (HBV + BCG) and peripheral blood pre-/post-immunization collected for transcriptomic and proteomic analysis as well as immune phenotyping. Project 1 will develop and employ cutting edge, cross-platform bioinformatics tools to identify pathways associated with CoP. Project 2, will apply unbiased immune phenotyping analysis tools to the same samples and translate to host immune parameters the in silico derived OMICs signatures. In Project 3 key molecular signals will be dissected in vitro to establish cause and effect. We have optimized all assays to work with small blood volumes and demonstrated feasibility in our pilot of rapid enrollment, stringently controlled sample collection and processing yielding cogent data that already hint at distinct vaccine-induced responses. Our cross-platform validation and correlation with CoP in a cohort containing training- and test-sets as well as a validation cohort, will identify biomarkers predicting neonatal vaccine immunogenicity i) pre-vaccination (Overall Aim 1) and ii) post-vaccination (Overall Aim 2). Delineation of the relevant mechanisms in vitro (Overall Aim 3) complements the output of this HIPC. Overall, our work will identify vaccine-induced molecular pathways key for successful vaccine-induced neonatal immune responses, thereby enhancing and accelerating vaccine development for those in greatest need.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = -$15,220 )
2024	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	5	4/9/2024	NON-COMPETING CONTINUATION	-$15,220
2024	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	5	4/9/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	5	3/26/2024	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = -$15,220

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	5	10/24/2022	SUPPLEMENT FOR EXPANSION	$0
2023	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	5	10/31/2022	SUPPLEMENT FOR EXPANSION	$0
2023	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	5	10/24/2022	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	5	11/3/2021	SUPPLEMENT FOR EXPANSION	$0
2022	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	003	5	12/2/2021	SUPPLEMENT FOR EXPANSION	$0
2022	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	004	5	12/3/2021	SUPPLEMENT FOR EXPANSION	$0
2022	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	006	5	8/31/2022	NON-COMPETING CONTINUATION	$0
2022	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	007	5	9/6/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	5	11/3/2021	SUPPLEMENT FOR EXPANSION	$0
2022	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	5	12/1/2021	SUPPLEMENT FOR EXPANSION	$0
2022	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	005	5	12/6/2021	SUPPLEMENT FOR EXPANSION	$0
2022	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	008	5	9/7/2022	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $10,401,978 )
2021	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	5	12/4/2020	NON-COMPETING CONTINUATION	$2,076,274
2021	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	008	5	1/21/2021	SUPPLEMENT FOR EXPANSION	$855,154
2021	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	011	5	3/9/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	006	5	1/15/2021	SUPPLEMENT FOR EXPANSION	$161,484
2021	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	005	5	1/14/2021	SUPPLEMENT FOR EXPANSION	$2,102,997
2021	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	009	5	1/28/2021	SUPPLEMENT FOR EXPANSION	$800,481
2021	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	012	5	8/5/2021	NON-COMPETING CONTINUATION	$0
2021	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	007	5	1/19/2021	SUPPLEMENT FOR EXPANSION	$2,275,700
2021	2021	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	010	5	2/25/2021	SUPPLEMENT FOR EXPANSION	$2,129,888
2021	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	4	1/8/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	4	1/8/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	004	4	1/8/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	003	4	1/8/2021	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $10,401,978

Issue Date FY: 2020 ( Subtotal = $7,262,248 )
2020	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	005	4	5/11/2020	SUPPLEMENT FOR EXPANSION	$2,174,014
2020	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	006	4	5/12/2020	SUPPLEMENT FOR EXPANSION	$308,143
2020	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	008	4	9/1/2020	SUPPLEMENT FOR EXPANSION	-$111,094
2020	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	4	1/27/2020	NON-COMPETING CONTINUATION	$0
2020	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	4	11/27/2019	NON-COMPETING CONTINUATION	$2,057,593
2020	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	010	4	9/9/2020	SUPPLEMENT FOR EXPANSION	$0
2020	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	009	4	9/4/2020	SUPPLEMENT FOR EXPANSION	$111,094
2020	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	007	4	8/10/2020	SUPPLEMENT FOR EXPANSION	$111,094
2020	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	004	4	5/8/2020	SUPPLEMENT FOR EXPANSION	$184,957
2020	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	002	4	4/23/2020	NON-COMPETING CONTINUATION	$0
2020	2020	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	003	4	5/7/2020	SUPPLEMENT FOR EXPANSION	$2,426,447
														Subtotal = $7,262,248

Issue Date FY: 2019 ( Subtotal = $1,984,196 )
2019	2019	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	3	11/13/2018	NON-COMPETING CONTINUATION	$1,984,196
														Subtotal = $1,984,196

Issue Date FY: 2018 ( Subtotal = $3,018,569 )
2018	2018	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	001	2	8/20/2018	NON-COMPETING CONTINUATION	$1,058,926
2018	2018	CHILDREN'S HOSPITAL CORPORATION, THE	300 LONGWOOD AVE	BOSTON	MA	02115	SUFFOLK	USA	Allergy and Infectious Diseases Research	000	2	12/2/2017	NON-COMPETING CONTINUATION	$1,959,643
														Subtotal = $3,018,569

Issue Date FY: 2017 ( Subtotal = $2,028,320 ) (Continued on the next page)
Grand Total All Awards = $24,680,091

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Systems Biology to Identify Biomarkers of Neonatal Vaccine Immunogenicity

Award Number: U19AI118608

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 12/27/2016

PERIOD OF PERFORMANCE END DATE: 11/30/2023

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