Center of Excellence · Vaccines

Advancing Vaccine Development Where the Burden Is Greatest

A coordinated network of vaccine trial sites, investigators, immunology laboratories, and cold-chain infrastructure supporting Phase I to IV vaccine research, field trials, and epidemic preparedness, under one quality system and one point of accountability.

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ICH GCP compliantPhase I to IV capabilityValidated cold chainMulti-country execution

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The Vaccines Center of Excellence

One Network. One Standard. One Accountable Partner.

Vaccine research demands what few markets can offer together: populations where the disease burden is real, sites qualified to run rigorous trials, laboratories that can measure immune response, and a cold chain that does not break. The Center brings those four things into one coordinated platform.

One network

Qualified vaccine trial sites, investigators, and laboratories across the continent.

One standard

ICH GCP-aligned quality management with central oversight and inspection readiness.

One accountable partner

A single commercial and operational relationship from feasibility to close-out.

Why Vaccines

Research Where the Disease Burden Is

Africa carries a disproportionate share of the world's vaccine-preventable disease burden. The overwhelming majority of global malaria cases and deaths occur in the WHO African Region, and the continent bears a heavy burden of tuberculosis, HIV, cholera, meningitis, and emerging pathogens.

Vaccines for these diseases must be tested in the populations that will use them. Immune response, efficacy, and safety cannot be reliably extrapolated from trials conducted elsewhere, and funders increasingly expect trials to reflect the populations they aim to protect.

The Center connects qualified sites, investigators, immunology laboratories, and cold-chain infrastructure into one platform, so sponsors can run rigorous vaccine research where it matters most, without assembling a network from scratch.

~95%of global malaria deaths in the WHO African Region¹

HighTB, HIV, and cholera burden¹

54Countries in scope

I to IVTrial phases supported

-80°CValidated cold-chain capability

MultiCountry coordinated delivery

¹ Source: WHO. Confirm edition and year before publication.

Therapeutic Focus Areas

Where the Center Focuses

Focus areas are reviewed annually by the Vaccines Scientific Advisory Group and reflect demonstrable network capability.

Malaria

Tuberculosis

HIV

RSV

Meningococcal disease

Cholera

Typhoid

Yellow fever

Measles and rubella

Viral hemorrhagic fevers

Mpox and emerging pathogens

Maternal immunization

Pediatric and routine immunization

Influenza

Pandemic preparedness

Therapeutic vaccines

Clinical Research Capabilities

How the Center Delivers

Clinical Development

Phase I to IV vaccine trials
First-in-human studies
Controlled human infection models
Large field efficacy trials
Adaptive and platform designs

Immunology and Laboratory

Immunogenicity assays
Serology and antibody titers
Cellular immunology
Correlates of protection
Biobanking and sample custody

Cold Chain and Supply

Validated 2 to 8°C, -20°C, and -80°C storage
Investigational product distribution
Vaccine accountability and reconciliation
Temperature excursion management
In-country depots and permits

Safety and Surveillance

AEFI reporting and management
Safety monitoring and DSMB support
Signal detection and aggregate reporting
Pharmacovigilance oversight
Outbreak and epidemic response

Field and Community

Community engagement and sensitization
Local-language informed consent
Household and cluster recruitment
Retention in long-term follow-up
Field site logistics

Regulatory and Quality

National regulatory and ethics submissions
Multi-country submission coordination
Import and export permits
GCP quality assurance
Inspection readiness

Cold Chain and Product Integrity

The Trial Fails at the Weakest Link

A vaccine trial can be scientifically flawless and still fail because a shipment sat on a runway. Temperature integrity is not a logistics detail; it is a data-integrity issue, and it is where vaccine studies in emerging markets most often break down.

Because depots, cold chain, and logistics sit inside our enterprise rather than outside it, product integrity is designed alongside the protocol. Excursions are prevented where possible, detected where not, and documented either way.

Validated storage at 2 to 8°C, -20°C, and -80°C
In-country clinical depots and distribution
Continuous temperature monitoring and excursion management
Vaccine accountability and reconciliation to the dose
Import and export permits and customs navigation
GDP-compliant transport to remote and field sites

Regulatory Pathway

Coordinated, Not Sequential

Multi-country vaccine studies start against one plan rather than several. GLS coordinates national regulatory and ethics submissions centrally to compress start-up timelines.

Strategy and dossier

Country-specific CTA planning and dossier preparation.

National authority

Submission, review, and approval by each national regulator.

Ethics review

National and institutional ethics committee approval.

Coordinated review

Submissions aligned across countries to run in parallel rather than in sequence.

Permits and activation

Import and export permits, activation, first participant enrolled.

GLS coordinates submissions centrally so multi-country studies start against one plan rather than several, and manages ethics, permits, and local representation in every market. Timelines are country-specific and modeled during feasibility.

The Vaccine Research Network

Sites Where the Disease Is, Qualified Before Activation

The Center brings together qualified vaccine trial sites, investigators, immunology laboratories, and field research infrastructure across Africa. Centralized governance, standardized quality systems, and coordinated operational support enable sponsors to run efficient, high-quality vaccine studies across multiple countries.

Participation is earned, not permanent. Organizations are admitted through formal qualification and reviewed annually against performance and quality standards.

Network composition is held as a confidential commercial asset. Individual institutions may be identified to a sponsor under confidentiality during feasibility.

Vaccine trial sites qualified against network standards
Investigators experienced in Ebola, COVID-19, HIV, TB, and malaria research
Immunology and serology laboratory capability
Field research infrastructure for large community trials
Validated cold chain and in-country depots
Coordinated multi-country delivery through one operational framework

What GLS Provides

The Services Behind the Network

Coordination is the outcome, not the service. GLS operates the vaccine network as a working platform.

Governance and qualification

Standing governance bodies with defined decision rights, and formal qualification of sites and investigators against one standard, reviewed annually.

Quality management and monitoring

A single ICH GCP-aligned quality system: SOPs, training, deviations and CAPA, audit, and continuous inspection readiness.

Harmonization

One protocol interpretation, one set of SOPs, one training standard, and one data model across countries and institutions.

Feasibility, contracts, and budgets

Centralized feasibility and realistic enrollment modeling, one master contract, and budgets negotiated once.

Regulatory, ethics, and safety

Multi-country regulatory and ethics submissions coordinated centrally, with AEFI reporting, safety monitoring, and defined escalation.

Cold chain, laboratory, and capacity

Validated cold chain and depots, immunology and serology coordination, and investigator development through GLS Academy.

Governance and Quality

How the Network Is Governed

Every institution and investigator operates under a common governance framework. Sites are qualified before admission, monitored during delivery, and reviewed annually. Quality management is centralized rather than delegated, so standards do not vary by country or site.

Executive Steering Committee

Ultimate decision authority. Owns strategy, risk appetite, network expansion, and escalations.

Quarterly

Vaccines Scientific Advisory Group

Independent scientific counsel: vaccine strategy, focus areas, feasibility standards, and scientific integrity.

Quarterly

Network Operations Committee

Operational delivery: site qualification decisions, feasibility, and performance management.

Monthly

Quality and Compliance Committee

Quality system ownership, audit program, deviations and CAPA, and inspection readiness.

Monthly

How institutions are qualified

STAGE 1

Expression of interest

Institutions and investigators apply through the qualification process.

STAGE 2

Qualification assessment

Structured assessment of expertise, trial history, compliance, and infrastructure.

STAGE 3

Quality clearance

Site qualification visit, SOP and pharmacy review, cold-chain and data-integrity check.

STAGE 4

Admission

Contracting, onboarding, and training completion.

ONGOING

Annual review

Performance and compliance review, with remediation, suspension, or withdrawal where standards are not met.

Why Sponsors Partner with GLS

Access Through a Single Partner

One commercial and operational relationship gives sponsors coordinated access to the whole vaccine network. Site identification, feasibility, regulatory and ethics submissions, cold chain, quality oversight, contracting, and execution all run through a single partner.

Curated site and investigator selection matched to the protocol
Centralized feasibility, budgeting, and contracting
Validated cold chain and product accountability
Multi-country regulatory and ethics coordination
Independent scientific input through the Advisory Group
A single point of accountability across the study lifecycle

One network

Qualified vaccine trial sites, investigators, and laboratories across the continent.

One standard

ICH GCP-aligned quality management with central oversight and inspection readiness.

One accountable partner

A single commercial and operational relationship from feasibility to close-out.

Become Part of the Network

An Open Partnership Platform

The Center expands through partnership with qualified vaccine trial sites, investigators, immunology laboratories, academic institutions, manufacturers, and global health collaborators. Interested organizations are invited to enter the GLS qualification process.

Apply to Join Partner with GLS Contact GLS

Advancing Vaccine Innovation Together

Whether you are developing preventive or therapeutic vaccines, running a large field efficacy trial, or preparing for the next outbreak, the Center provides a governed, collaborative platform to accelerate development where the burden is greatest.

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